A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Sponsor: Radius Health, Inc.

Radius Health, Inc. 
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Disclosure Statement 
This document contains information that is confidential and proprietary to Radius Health, Incorporated 
(Radius). This information is being provided to you solely for the purpose of evaluation and/or conducting a 
clinical trial for Radius. You may disclose the contents of this document only to study personnel under your 
supervision and/or to your institutional review board(s) or ethics committee(s) who need to know the contents 
for this purpose and who have been advised on the confidential nature of the document. 
CLINICAL STUDY PROTOCOL 
AMENDMENT 1 
A Prospective, Single Arm Study to Evaluate the PK, PD and Usability of 
Abaloparatide-sMTS in Postmenopausal Women with Low Bone Mineral 
Density 
This study will be conducted according to the protocol and in compliance with Good Clinical 
Practice (GCP), the ethical principles stated in the Declaration of Helsinki, and other applicable 
regulatory requirements. 
Protocol Number: 
Protocol BA058-05-022 
Protocol Date: 
18 March 2019 
IND Number: 
73,176 
Study Sponsor: 
Radius Health, Inc. (Radius) 
Tel: (617) 551-4700; Fax:
Contract Research 
Organization (CRO) 
Pharmaceutical Research Associates, Inc 
9755 Ridge Drive 
Lenexa, Kansas 66219 
Version number 
Version date 
Original 
21 January 2019 
Amendment 1 
18 March 2019 
NCT #NCT04366726

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TABLE OF CONTENTS 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF TABLES ...........................................................................................................................6 
LIST OF FIGURES .........................................................................................................................6 
LIST OF ABBREVIATIONS ..........................................................................................................7 
SYNOPSIS .......................................................................................................................................9 
1. 
INTRODUCTION ......................................................................................................16 
1.1. 
Background .................................................................................................................16 
1.1.1. 
Disease and Study Drug Background .........................................................................17 
1.1.2. 
Study Drug Development ...........................................................................................18 
1.1.2.1. 
Nonclinical Studies .....................................................................................................18 
1.1.2.2. 
Clinical Studies ...........................................................................................................18 
1.2. 
Study Rationale ...........................................................................................................20 
1.3. 
Dose Rationale ............................................................................................................21 
2. 
STUDY OBJECTIVES AND ENDPOINTS..............................................................22 
2.1. 
Objective .....................................................................................................................22 
2.2. 
Primary Endpoint ........................................................................................................22 
2.3. 
Secondary Endpoints ..................................................................................................22 
2.3.1. 
Pharmacodynamic (PD) Endpoints.............................................................................22 
2.3.2. 
Other Endpoints ..........................................................................................................22 
2.3.3. 
Safety and Tolerability Endpoints ..............................................................................22 
3. 
STUDY DESIGN .......................................................................................................23 
3.1. 
Description of the Study Design .................................................................................23 
4. 
SELECTION OF STUDY POPULATION ................................................................24 
4.1. 
Inclusion Criteria ........................................................................................................24 
4.2. 
Exclusion Criteria .......................................................................................................25 
4.3. 
Subject Withdrawal or Termination ...........................................................................26 
4.3.1. 
Reasons for Withdrawal or Termination ....................................................................26 
4.3.2. 
Handling of Subject Withdrawals or Terminations ....................................................27 
4.4. 
Concomitant Medications ...........................................................................................27 
4.5. 
Prohibited Medications ...............................................................................................27 
4.6. 
Premature Termination or Suspension of Study .........................................................28 

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4.7. 
Temporary Suspension of Treatment ..........................................................................28 
5. 
STUDY DRUG ADMINISTRATION AND MANAGEMENT................................29 
5.1. 
Study Medication ........................................................................................................29 
5.1.1. 
Abaloparatide-sMTS ...................................................................................................29 
5.2. 
Packaging, Labeling and Storage ...............................................................................29 
5.2.1. 
Packaging and Labeling ..............................................................................................29 
5.2.2. 
Storage ........................................................................................................................29 
5.3. 
Study Medication Administration ...............................................................................29 
5.4. 
Treatment Assignment ................................................................................................30 
5.5. 
Dosing and Administration .........................................................................................30 
5.6. 
Treatment Compliance ................................................................................................30 
5.7. 
Drug Accountability ...................................................................................................31 
6. 
STUDY PROCEDURES AND SCHEDULE ............................................................32 
6.1. 
Study Procedures ........................................................................................................32 
6.1.1. 
Study Specific Procedures ..........................................................................................32 
6.2. 
Study Schedule ...........................................................................................................32 
6.2.1. 
Schedule of Assessments and Procedures ..................................................................32 
6.2.2. 
Informed Consent Process ..........................................................................................36 
6.2.3. 
Assigning Subject Numbers .......................................................................................36 
6.2.4. 
Subject and Disease Characteristics ...........................................................................36 
6.2.5. 
Screening Period (Visit 1; Days -67 to -8) .................................................................36 
6.2.6. 
Pre-treatment Period (Days -7 to -1) ..........................................................................37 
6.2.7. 
Treatment Period ........................................................................................................37 
6.2.7.1. 
Visit 3 (Day 1) ............................................................................................................37 
6.2.7.2. 
Visit 4 (Day 15) ..........................................................................................................38 
6.2.7.3. 
Visit 5 / End of Treatment (Day 29) ...........................................................................39 
6.2.8. 
Visit 6/Follow up (Day 36) .........................................................................................40 
6.2.9. 
Unscheduled Visit .......................................................................................................40 
6.3. 
Vital Signs and Physical Examinations ......................................................................40 
6.4. 
12-Lead Electrocardiogram ........................................................................................41 
6.5. 
Laboratory Evaluations ...............................................................................................41 
6.5.1. 
Clinical Laboratory Evaluations .................................................................................41 
6.5.2. 
Serum Markers of Bone Metabolism ..........................................................................42 

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6.5.3. 
Specimen Preparation, Handling and Storage ............................................................42 
6.6. 
Imaging Procedures ....................................................................................................42 
6.6.1. 
Dual Energy X-ray Absorptiometry (DXA) ...............................................................42 
6.6.2. 
Local Tolerance ..........................................................................................................43 
6.6.2.1. 
Investigator assessment of signs of local tolerance ....................................................43 
6.6.2.2. 
Subject assessment of symptoms of local tolerance ...................................................43 
6.6.3. 
Residual Drug .............................................................................................................43 
6.6.4. 
Assessment of Patch Adhesion ...................................................................................44 
6.6.5. 
Assessment of Subject Reported Outcomes ...............................................................44 
6.7. 
Discontinuation from the Study ..................................................................................45 
6.7.1. 
Withdrawal of Consent ...............................................................................................45 
6.7.2. 
Early Study Termination .............................................................................................45 
7. 
ADVERSE EVENT AND SERIOUS ADVERSE EVENT 
DOCUMENTATION .................................................................................................46 
7.1. 
Evaluation of Safety ...................................................................................................46 
7.1.1. 
Adverse Event .............................................................................................................46 
7.1.2. 
Serious Adverse Event (SAE) ....................................................................................47 
7.1.3. 
Recording an Adverse Event ......................................................................................47 
7.1.3.1. 
Serious and Unanticipated Adverse Device Effects for Abaloparatide-sMTS ...........49 
7.1.4. 
Serious Adverse Event Reporting ...............................................................................49 
7.1.5. 
Device Reporting ........................................................................................................50 
7.1.6. 
Follow-up of Adverse Events .....................................................................................50 
7.1.7. 
Overdose .....................................................................................................................50 
7.1.8. 
Regulatory Agency, Institutional Review Board, and Site Reporting ........................50 
7.2. 
Study Completion and Post-Study Treatment .............................................................50 
7.3. 
Lost to Follow-up .......................................................................................................51 
8. 
STATISTICAL CONSIDERATIONS .......................................................................52 
8.1. 
Statistical and Analytical Plans ..................................................................................52 
8.2. 
Statistical Hypotheses .................................................................................................52 
8.3. 
Analysis Datasets ........................................................................................................52 
8.3.1. 
Population for Analysis ..............................................................................................52 
8.4. 
Description of Statistical Methods ..............................................................................52 
8.4.1. 
General Approach .......................................................................................................52 

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8.4.2. 
Analysis of the Primary Endpoint ...............................................................................52 
8.4.3. 
Analysis of Secondary Endpoints ...............................................................................53 
8.4.4. 
Safety Analyses...........................................................................................................55 
8.4.5. 
Adherence and Retention Analyses ............................................................................55 
8.4.6. 
Baseline Descriptive Statistics ....................................................................................55 
8.4.7. 
Interim Analyses .........................................................................................................56 
8.4.8. 
Additional Subgroup Analyses ...................................................................................56 
8.4.9. 
Multiple Comparison/Multiplicity ..............................................................................56 
8.4.10. 
Tabulation of Individual Response Data ....................................................................56 
8.4.11. 
Exploratory Analyses ..................................................................................................56 
8.5. 
Sample Size Calculation .............................................................................................56 
8.6. 
Measures to Minimize Bias ........................................................................................56 
8.7. 
Enrollment/Randomization/Masking Procedures .......................................................56 
9. 
ADMINISTRATIVE REQUIREMENTS ..................................................................57 
9.1. 
Ethical Considerations ................................................................................................57 
9.2. 
Subject Information and Informed Consent ...............................................................57 
9.3. 
Investigator Compliance .............................................................................................57 
9.4. 
Access to Records .......................................................................................................57 
9.5. 
Subject and Data Confidentiality ................................................................................58 
9.6. 
Research Use of Stored Human Samples, Specimens, or Data ..................................58 
9.7. 
Data Quality Assurance ..............................................................................................58 
9.8. 
Monitoring ..................................................................................................................59 
9.9. 
Data Collection and Management Responsibilities ....................................................59 
9.10. 
Study Records Retention ............................................................................................60 
9.11. 
Publication and Data Sharing Policy ..........................................................................60 
10. 
LITERATURE REFERENCES ..................................................................................61 

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LIST OF TABLES 
Table 1: 
Schedule of Assessments ............................................................................................33 
Table 2: 
Clinical Laboratory Tests............................................................................................41 
 
 
 
LIST OF FIGURES 
Figure 1: 
Study Design ...............................................................................................................23 

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LIST OF ABBREVIATIONS 
 
Abbreviation 
Term 
 
°C 
Degree Celsius 
°F 
Degree Fahrenheit 
µg 
Microgram 
µL 
Microliter 
µmol 
Micromole 
AE 
Adverse event 
AESI 
Adverse event of special interest 
AUC 
Area under the concentration-time curve 
BMD 
Bone mineral density 
bpm 
Beats per minute 
BSAP 
Bone-specific alkaline phosphatase 
cAMP 
Cyclic adenosine monophosphate 
cm 
Centimeter 
Cmax 
Maximum plasma concentration 
CRF 
Case report form 
CSR 
Clinical study report 
DXA 
Dual energy X-ray absorptiometry 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EOT 
End of Treatment 
g 
Gram 
GCP 
Good clinical practice 
GLP 
Good laboratory practice 
GMP 
Good manufacturing practice 
Geo 
Geometric 
HRT 
Hormone replacement therapy 
IB 
Investigator's Brochure 
IC 
Informed consent 
ICF 
Informed consent form 
IRB 
Institutional review board 
IU 
International unit 
IV 
Intravenous 
kg 
Kilogram 
L 
Liter 
MedDRA 
Medical dictionary for regulatory activities 
mg 
Milligram 

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Abbreviation 
Term 
 
mL 
Milliliter 
mmHg 
Millimeter of mercury 
ng 
Nanogram 
PA 
Posterior-anterior 
PD 
Pharmacodynamic 
pg 
Picogram 
PK 
Pharmacokinetic 
PMO 
Post-menopausal Osteoporosis 
PT 
Prothrombin time 
PTH 
Parathyroid hormone 
PTHrP 
Parathyroid hormone related peptide 
PTT 
Partial thromboplastin time 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SC 
Subcutaneous 
SD 
Standard deviation 
SE 
Standard error 
sMTS 
Solid microstructured transdermal system 
SOA 
Schedule of Assessments 
SOC 
System organ class 
s-PINP 
Serum procollagen type 1 N propeptide 
TEAEs 
Treatment emergent adverse events 
TSH 
Thyroid stimulating hormone 
TSQM-9 
Treatment satisfaction questionnaire for medication short form 
UADE 
Unanticipated adverse device effect 
ULN 
Upper limit of normal 
WHO 
World Health Organization 

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SYNOPSIS 
 
Name of Sponsor/Company: 
Radius Health, Inc. (RADIUS) 
Name of Investigational Product: 
Abaloparatide-solid microstructured transdermal system (sMTS) (formerly called BA058) 
Name of Active Ingredient: 
Abaloparatide 
Protocol Number: 
BA058-05-022 
Phase: 1b 
Country: United States 
Title of Study: 
A Prospective, Single Arm Study to Evaluate the PK, PD and the Usability of Abaloparatide-sMTS in 
Postmenopausal Women with Low Bone Density 
Study center(s): Pharmaceutical Research Associates, Inc, Lenexa, Kansas 
Objectives: 
Primary: 
• 
The primary objective of this study is to evaluate the ability of subjects to self-administer 
abaloparatide-sMTS (300 µg) over a period of 29 days based on pharmacokinetics (PK) and 
pharmacodynamic (PD) markers. 
Secondary: 
• 
The secondary objective is to evaluate the usability of abaloparatide-sMTS as measured by 
incidence of user errors, overall subject acceptability, preference, satisfaction and adherence 
to study therapy. 
• 
Other secondary objectives include an evaluation of overall safety and tolerability of 
abaloparatide-sMTS as assessed by treatment emergent adverse events (TEAEs), vital signs 
(orthostatic blood pressure, pulse rate, body temperature, and respiration rate), ECGs, 
laboratory tests (chemistry, hematology, urinalyses) and local tolerance. 
Study Design and Methodology: 
In this study, the effectiveness of subjects to self-administer 300 µg abaloparatide-sMTS once-daily on 
the thigh for 5 minutes for a period of 29 days will be assessed through PK and PD (bone biomarker) 
analyses. Before the start of treatment, subjects will receive training on abaloparatide-sMTS application. 
During the study, the subjects will record their user experience, incidence of user errors; the subject and 
investigator will both assess local tolerance (symptoms [subject] and signs [investigator] of local skin 
reactions). On study visit days, subjects will self-administer abaloparatide-sMTS and will have blood 
samples drawn for PK and PD measurements, including an evaluation of subject preference parameters. 
The detailed study design will be as follows: 
Screening Period (Days -67 to -8): 
The initial period will be the Screening Period where clinical evaluations will be done from Days -67 to 
-8 which includes signing of the informed consent, medical history, comprehensive physical 

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examination, measurement of vital signs, ECG, hematology, serum chemistry (including calcium, 
albumin, and phosphorus), coagulation tests, urinalysis, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin 
D, and serum pregnancy testing if needed. Urine will be collected for urinalysis and urine drug and 
alcohol screen. In addition, a 24 hour urine collection will begin on Day -8 and patients will bring in 
their sample on Day -7. 
If a subject does not have a recent (within 12 months) bone mineral density (BMD) scan, a scan will be 
performed to ensure the subject meets the BMD requirement. Note: Every effort will be made to enroll 
subjects with a T-score of -2.0 or lower but > -5.0; for those with scores higher than -2.0, preference 
should be given to subjects with lower BMD scores. 
Pre-Treatment Period (Days -7 to -1): 
Based on screening evaluations, eligible subjects will enter a 1-week pre-treatment period where vitamin 
D and calcium supplementation will be initiated. 
Treatment Period, Day 1: 
Subjects will be admitted to the clinical research facility on Day 1 of the treatment period. Subjects who 
continue to meet the study criteria will undergo a symptom-directed physical exam and assessments of 
vital signs, ECG, updated medical history including concomitant medications, and review of any adverse 
events (AEs). Other predose assessments include: blood collections for PK, hematology, serum 
chemistry (including calcium, albumin, and phosphorus), coagulation tests, urinalysis, cyclic adenosine 
monophosphate (cAMP), and baseline measurements of s-PINP. Urine will be collected for urinalysis 
and for drug and alcohol testing. The application site will be prepared and cleaned, and predose 
assessment of the application site will be done by the investigator and the subject. 
Immediately before initial dosing (Day 1), the subject will be trained in abaloparatide-sMTS application 
and instructed how to perform a self-assessment of symptoms of local skin reaction of the application 
site. After the training, the subject will assess the application site for symptoms of local skin reactions 
prior to application of abaloparatide-sMTS and will then self-administer the study drug. A subject diary 
will be provided for recording of user errors in abaloparatide-sMTS application, patch adhesion, and 
assessment of local tolerance (symptoms of local skin reactions). 
Self-assessments of symptoms of local skin reaction will be performed by the subject 5 minutes after 
application of abaloparatide-sMTS and 1 hour after application of abaloparatide-sMTS on the day of 
clinic visits. Subject will also be instructed to conduct this assessment of symptoms of local skin 
reactions, user errors, and an assessment of patch adhesion, beginning Day 1 until Day 29 or end of 
treatment (EOT) visit. 
Investigators will perform an assessment of signs of local skin reaction on the application site prior to 
abaloparatide-sMTS application, 5 minutes after application (ie, immediately upon removal of 
abaloparatide-sMTS), and 1 hour after abaloparatide-sMTS application. 
Subject preference for treatment attributes, and acceptability will also be assessed by the subjects. 
Pharmacokinetic measurements will be assessed at 10 minutes, 20 minutes, 30 minutes, 1, 1.5, 2, 3 and 
4 hours after application of abaloparatide-sMTS. Pulse rate will be recorded 15 minutes after 
abaloparatide-sMTS application with a repeat ECG taken 1 hour after abaloparatide-sMTS application. 
Blood will be drawn for assessment of cAMP at 30 minutes after abaloparatide-sMTS application and 
for assessment of serum calcium, albumin, and phosphorus at 4 hours after abaloparatide-sMTS 
application. 
Following completion of Day 1 study activities, the subject will be sent home with the diary and a 
2-week supply of abaloparatide-sMTS for self-administration together with locally sourced vitamin D 

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and calcium supplements. The subject will be instructed to self-administer abaloparatide-sMTS every 
day, take the vitamin D and calcium supplements, and complete the subject diary entries as outlined 
above. 
Treatment Period, Day 15 and Day 29/EOT: 
On Days 15 and 29, the subject will be readmitted to the clinical research facility. A review of AEs and 
concomitant medications will be conducted and predose assessments will include: symptom-directed 
physical exam, vital sign measurements, ECG, blood collections for PK, hematology, serum chemistry 
(including calcium, albumin, and phosphorus), coagulation tests, urinalysis, cAMP, and s-PINP. 
Following completion of the predose assessments, the subject will self-administer the product. Used 
abaloparatide-sMTS and swab for residual drug and swab residuals will be collected. 
Symptoms of local skin reaction will be assessed by the subject (prior to application of abaloparatide 
sMTS, 5 minutes after application (ie, immediately upon removal of abaloparatide-sMTS), and 1 hour 
after abaloparatide-sMTS application) and recorded in the subject diary. The subject will also assess 
patch adhesion and user errors. Subjects will also complete user experience assessments including: 
treatment satisfaction questionnaire for medication short form (TSQM9) Global Satisfaction and 
convenience domains; 5-point Likert-like scale of acceptability; and subject preference for treatment 
attributes. 
The study staff will review the prior entries in the diary and provide additional training on how to 
complete the diary, as needed. In addition, the study staff will conduct an investigator assessment of 
signs of local skin reactions. 
Post application assessments will include blood draws for cAMP, serum calcium, albumin, and 
phosphorus urinalysis. PK measurements will be assessed 10 minutes, 20 minutes, 30 minutes, 1, 1.5, 2, 
3, and 4 hours after abaloparatide-sMTS application. 
On Day 15, the subject will be resupplied with abaloparatide-sMTS, and vitamin D and calcium 
supplements. Subjects will be instructed to continue recording user experience, acceptability and 
preferences for treatment attributes, user errors, patch adhesion, symptoms of local skin reactions, and 
information on study drug accountability in the subject diary. 
Follow-up Visit (Day 36) 
A follow up visit 7-days following Visit 5/EOT can be done either in clinic or remotely via a phone 
follow up. Assessment of local tolerance will be conducted for subjects with ongoing signs or symptoms 
of local skin reactions and a review of AEs and concomitant medications will be done. 
Number of subjects (planned): 
Approximately 22 subjects will be enrolled and treated to ensure a minimum of 18 subjects complete the 
29-day treatment and study procedures. Note: Every effort will be made to enroll subjects with a T-score 
of -2.0 or lower but > -5.0; for those with scores higher than -2.0, preference should be given to subjects 
with lower BMD scores. 
Diagnosis and main criteria for inclusion and exclusion criteria: 
Inclusion criteria: 
Subjects will be included in the study if they meet all of the following inclusion criteria: 
1. Healthy ambulatory female from 50 to 85 years of age (inclusive) 

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2. Postmenopausal for at least 2 years. Postmenopausal status will be established by a history of 
amenorrhea for at least 2 years, and negative serum pregnancy test or an elevated serum follicle- 
stimulating hormone (FSH) value of ≥ 30 IU/L. 
3. BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine (L1–L4) 
or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA). Note: Every 
effort will be made to enroll subjects with a T-score of -2.0 or lower but > -5.0; for those with 
scores higher than -2.0, preference should be given to subjects with lower BMD scores. 
4. Good general health as determined by medical history and physical examination (including vital 
signs), has a body mass index of up to 33 kg/m2, and is without evidence of clinically significant 
abnormality that may increase the risk associated with study participation or investigational 
product administration, or may interfere with compliance or the interpretation of study results, 
and would make the subject inappropriate for this study in the opinion of the Investigator 
5. Serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, 
alkaline phosphatase, and thyroid stimulating hormone (TSH) values all within the normal range 
during the Screening Period. Subjects with minor elevations or reductions in serum calcium may 
be enrolled if serum ionized calcium is normal. Any subject with an elevated alkaline 
phosphatase value, and who meets all other entry criteria would be required to have a normal 
bone-specific alkaline phosphatase to be enrolled 
6. Serum 25-hydroxyvitamin D values ≥ 20 ng/mL. 
7. Resting 12-lead electrocardiogram at screening shows no clinically significant abnormality. 
8. Systolic blood pressure is ≥ 100 and ≤ 155 mmHg, diastolic blood pressure is ≥ 40 and 
≤ 95 mmHg, and heart rate is ≥ 45 and ≤ 100 bpm (taken sitting) 
9. No clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells, and 
platelets, or usual serum chemistry, including electrolytes, renal function, liver function and 
serum proteins, that might be expected to interfere with the subject’s health and/or medical 
treatment during the study 
10. Read, understood, and signed the written informed consent form 
11. Hemoglobin value ≥ 12.0 g/dL. 
Exclusion criteria: 
Subjects who meet any of the following exclusion criteria will be excluded from the study: 
1. History of bone disorders (eg, Paget’s disease) other than postmenopausal osteoporosis 
2. History of prior external beam or implant radiation therapy involving the skeleton, other than 
radioiodine 
3. History of Cushing’s disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within 
the past year 
4. History of significantly impaired renal function (serum creatinine > 177 μmol/L or 
> 2.0 mg/dL). If serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance 
(Cockcroft-Gault) must be ≥ 37 mL/min 
5. History of any cancer within the past 5 years (other than basal cell or squamous cancer of the 
skin) 
6. History of osteosarcoma at any time 
7. History of nephrolithiasis or urolithiasis within the past 5 years 

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8. Application site (thigh) compromised by scars, inflammation or skin conditions to an extent that 
may compromise uniformity of abaloparatide-sMTS application or drug delivery (nevi, plaques, 
tattoos, scars, piercing, etc.) 
Medication-related exclusion criteria: 
9. Known history of hypersensitivity to any of the test materials or related compounds 
10. Prior therapeutic treatment with PTH- or PTH-related peptide (PTHrP)-derived drugs, or bone 
anabolic drugs including abaloparatide, teriparatide, or PTH(1-84). Subjects who received 
abaloparatide in prior Phase 1 studies are not excluded 
11. Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the 
past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy 
(3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to 
enrollment 
12. Treatment with fluoride or strontium in the past 5 years or prior treatment with gallium nitrate or 
bone-acting investigational agents at any time 
13. Prior treatment with calcitonin or tibolone in the past 6 months 
14. Treatment with denosumab within the past 18 months 
15. Treatment with anticonvulsants that affect vitamin D metabolism (phenobarbital, phenytoin, 
carbamazepine or primidone) or with chronic heparin within the 6 months prior to the Screening 
Period 
16. Treated with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus) within the past 
90 days. 
17. Prior treatment with selective estrogen receptor modulators (except hormone replacement 
therapy) within past 6 months or daily treatment with oral, intranasal, or inhaled corticosteroids 
within the 12 months prior to the Screening Period. Occasional use of all corticosteroids (for 
seasonal allergies or asthma) is not exclusionary. Use of low dose oral corticosteroids 
(eg, ≤ 5 mg/day of prednisone or the relative equivalent dose of another corticosteroid) is also 
not exclusionary. 
18. Participation is another clinical trial with any investigational drug or device within 3 months or 
5 half-lives of the investigational drug (if known), whichever is longer, of study drug 
administration. 
Lifestyle-related exclusion criteria: 
19. Abnormal nutritional status as assessed by the investigator including abnormal diets and 
excessive or unusual vitamin or herbal intakes; vitamin D intake of ≥ 4,000 IU/day or vitamin A 
intake of ≥ 10,000 IU/day. Short term use of high doses of vitamin D to bolster endogenous 
vitamin D levels for study entry during the screening period is not exclusionary 
20. Active drug or alcohol dependence or abuse (excluding tobacco or medicinal or recreational 
marijuana use where legal unless there is evidence of abuse) within 12 months of the screening 
period; or evidence of such abuse (in the opinion of the investigator). 
Investigational product, dosage and mode of administration: 
The 300 µg abaloparatide-sMTS will be applied to the thigh and worn for 5 minutes once a day, 
according to the Instructions for Use 
Duration of treatment: 

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The study will consist of a Screening Period, a 1-week Pre-treatment period, a treatment period of 
29 days and a 7-day follow-up period. Any subject that has a reported treatment-related AE during the 
study will be followed until complete resolution or stabilization, or until the subject is lost to follow-up. 
Reference therapy, dosage and mode of administration: 
N/A 
Criteria for evaluation: 
Pharmacokinetics/ Pharmacodynamics: 
Pharmacokinetics Measurements: 
Individual plasma concentrations of abaloparatide will be tabulated by visit and sampling time and 
summarized descriptively. Individual and summary profiles will also be plotted. The plasma 
concentration-time profiles of abaloparatide will be analyzed using non-compartmental methods, and 
calculations will be made using the actual time since dose. Data permitting, the PK parameters 
maximum plasma concentration (Cmax), time of maximum observed plasma concentration (tmax), area 
under the plasma concentration-time curve (AUC0-t), area under the curve extrapolated to infinity 
(AUC0-inf), elimination rate constant (λz), and half-life (t1/2) will be derived. Derived PK parameters 
will be listed and summarized by visit. Descriptive statistics (mean, standard deviation [SD], coefficient 
of variation [CV%], minimum, median, maximum, geometric mean, and geometric CV%) will be 
provided by visit (Day 1, Day 15, and Day 29). 
Pharmacodynamic Measurements: 
Measurements of s-PINP will be summarized descriptively for each visit. Changes and percent changes 
from baseline, as well as ratio of post-baseline value over baseline value, will be summarized 
descriptively with 90% confidence interval by visit. Individual and summary profiles will also be 
plotted. 
The actual values, change from baseline values, and the percentage change from baseline values for 
serum calcium (albumin-corrected), serum phosphorus, and cAMP will be summarized using descriptive 
statistics by visit and timepoint. 
User experience measurements: 
User errors and user preference data will be tabulated and summarized descriptively. 
For the Treatment Satisfaction Questionnaire for Medication – Short Form (TSQM-9), only the global 
satisfaction and convenience domains will be assessed. The mean TSQM-9 score (±standard error [SE]) 
for each domain will be tabulated for Day 15 and Day 29 for the subjects who complete the study. 
The mean (±SE) of the subject acceptability score will be tabulated for Days 1, 15, and 29. 
Pending data availability, the association between subject preference for treatment attributes and 
subsequent acceptability and satisfaction will be evaluated separate for outcome (effectiveness/safety) 
and other attributes (duration, frequency of use, mode of intake). 
Safety: 
All safety analyses will be conducted using the Safety Population and will be descriptive in nature. 
Study drug exposure and study drug compliance will be calculated. The duration of study drug exposure, 
total dose received and percent compliance will be summarized. 
Medical history, physical examination, demographics and baseline characteristics will be summarized 
and presented. Medical history will be presented by MedDRA system organ class and preferred term, 
summarizing the proportion of subjects who have a condition noted. Results from the baseline physical 
examination will be summarized by body system as recorded in the eCRF. 

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Descriptive statistics for laboratory data (including serum calcium and albumin), vital signs (including 
orthostatic BP), and ECGs will be provided by visit and time point (when applicable). For laboratory 
data, vital signs and ECGs, absolute results and changes from baseline (and changes from predose for 
ECG heart rate) will be presented. 
Sample Size and Power Calculation: 
The study being performed is a hypothesis generating study and the sample size is based on previous 
trial experience without a formal power calculation. 
Statistical methods: 
The log transformed AUC0-t, AUC0-inf, and Cmax will be compared among the visits, using Day 1 as the 
reference in the comparison. Point estimates and 90% CIs for differences in PK parameter values 
between visits will be obtained. 
Summary tabulations will display the number of observations, mean, SD, median, minimum, and 
maximum for continuous variables, and the number and percent per category for categorical data. 
Demographics and baseline characteristics of the subject population will be summarized. Summary 
tables, including frequency counts or descriptive statistics, as appropriate, will be prepared for AEs, 
serious AEs (SAEs), AESIs, AEs resulting in discontinuation of treatment or withdrawal from the study, 
and changes in clinical laboratory tests. In addition, subject listings will be presented for AEs, vital 
signs, clinical laboratory tests, ECGs, local tolerance, and user experience assessments. 

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1. 
INTRODUCTION 
1.1. 
Background 
Human parathyroid hormone (PTH) is a naturally occurring 84 amino acid hormone and is 
primarily a regulator of calcium homeostasis (Mannstadt 1999). PTH acts directly on bone to 
increase calcium resorption, on the gastrointestinal system to increase calcium absorption, and 
on the kidney to increase calcium reabsorption and 1,25-dihydroxyvitamin D production. In 
turn, PTH levels are tightly regulated by calcium and vitamin D levels. When given 
intermittently at low doses, PTH has a well-documented anabolic effect on bone, and can 
increase bone mineral density (BMD) in a number of intact animal models and in osteoporotic 
patients (Dempster 1993). 
Abaloparatide (marketed as TYMLOS® in the United States [US]) was approved for use on 28 
April 2017 in the US for the treatment of postmenopausal women with osteoporosis at high 
risk for fracture. Abaloparatide is a novel, synthetic, 34 amino acid peptides designed to be a 
potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor 
(PTHR1) signaling pathway with 41% homology to PTH[1–34]) and 76% homology to human 
PTHrP[1–34]. Abaloparatide is differentiated from PTH and PTHrP ligands based on its high 
affinity and > 1,000-fold greater selectivity for the G protein-coupled (RG) vs the non-G 
protein-coupled (R0) conformation of PTHR1 (Hattersley 2016). Differential PTHR1-RG 
binding with abaloparatide results in potent and transient intracellular cyclic AMP (cAMP) 
signaling. In nonclinical studies, the transient PTHR1 activation with abaloparatide strongly 
favors bone anabolism with a limited effect on bone resorption (Makino 2015). Thus, 
abaloparatide was developed with the expectation that it would be effective at increasing BMD 
and reducing fracture in individuals with osteoporosis, but with a limited effect on bone 
resorption and a reduced risk of hypercalcemia. 
TYMLOS is supplied in a single-patient-use prefilled pen that delivers 80 μg of abaloparatide 
as a subcutaneous (SC) injection into the periumbilical region of the abdomen. Abaloparatide 
administered as a SC injection is referred to throughout this document as abaloparatide-SC. 
RADIUS, in collaboration with 3M, has developed a short wear time intradermal method of 
administration for abaloparatide to provide an alternative route of administration that may be 
preferred by some patients, thus, reducing a barrier for anabolic therapy. This is referred to as 
the abaloparatide-solid Microstructured Transdermal System (abaloparatide-sMTS). 
Abaloparatide-sMTS is a drug device combination product consisting of Abaloparatide: ZnCl2 
, HCl 
, coated onto the sMTS array and contained within the 
following packaging system: 
• The primary packaging components with a delivery function includes: 
− An array patch for adhering the drug formulation-coated sMTS array to the skin 
− An insert that holds and protects the coated array patch and inserts it into an 
applicator 
• The primary packaging components with a protective function includes: 

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− A pod that holds the insert 
− A lid heat sealed to the edges of the pod 
• The secondary packaging includes: 
− A desiccant 
− A foil patch, heat sealed, that contains the sealed pod and desiccant. 
The applicator is a spring powered device that, when pressed against the skin of the thigh, 
inserts the drug formulation-coated sMTS array tips into the dermis at a predetermined force. In 
contrast to traditional transdermal delivery systems, the sMTS array penetrates the stratum 
corneum to deliver the drug formulation following a short wear time (5 minutes). 
 
1.1.1. 
Disease and Study Drug Background 
Osteoporosis is a systemic skeletal disease characterized by low bone mass and 
microarchitectural deterioration of bone tissue that leads to enhanced fragility and increased risk 
of fractures (Rizzoli 2001). This disease is characterized by low BMD and fractures. The 
fractures associated with the greatest morbidity and mortality, as well as economic burden to 
society, together make up the clinically significant and medically relevant group termed major 
osteoporotic fractures. In the US, there are an estimated 2 million osteoporotic fractures 
annually (Litwic 2014). The number of osteoporotic fractures is projected to increase in both 
men and women by more than 3-fold over the next 50 years as a result of the aging population 
(WHO 2007). 
Spinal fractures have also been associated with poor outcomes and high mortality rates (Suzuki 
2008). It has been reported that once a patient had sustained a vertebral fracture, the risk of a 
subsequent vertebral fracture increases by >300% and the risk of a subsequent hip fracture 
increased by 200% (Black 1999). Additional studies have shown that almost half of the patients 
with a prior vertebral fracture will experience additional vertebral fractures within 3 years, many 
within the first year (Robinson 2002; Lindsay 2001). Those patients who sustained a vertebral 
body fragility fracture showed a prolonged course that can lead to significant disability even one 
year later (Suzuki 2008). Patients with a diagnosis of osteoporosis who have had any fracture 
have an 86% increase in their risk for another fracture (Kanis 2004). With the severity of these 
implications, prevention of a secondary fracture has become a primary focus from a patient care 
and societal standpoint. 
Major osteoporotic fractures (those of the wrist, shoulder, hip and clinical spine) account for 94% 
of the fracture risk for women with low or minimal trauma (Ensrud 2016). Major osteoporotic 
fractures contribute to accumulated frailty such that the Frailty Index is significantly larger in 
those elderly women who have experienced a major osteoporotic fracture. As a result, these 
women have worsening frailty and greater morbidity after a major osteoporotic fracture (Li 
2015). The Frailty Index was associated with a predicted increase in the risk of falls, fractures, 
death and overnight hospitalizations (Li 2014). Consequently, prevention of clinically significant 
and medically relevant major osteoporotic fractures will reduce health care costs and benefit 

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postmenopausal women due to reduced frailty, reduced risk of falls, fractures, hospitalizations 
and death. 
Bone remodeling occurs through the action of osteoclasts, which are involved in the resorption 
of bone followed by the formation of new bone by osteoblasts. In addition to continued use of 
calcium and vitamin D, the current therapeutic approach to the treatment of osteoporosis 
through inhibition of bone resorption includes agents such as bisphosphonates (Rosen 2005), or 
the monoclonal antibody denosumab, that inhibits the action of osteoclasts by binding to 
receptor activator of nuclear factor kappa-B ligand. An alternative approach has been to tip the 
balance between osteoblastic bone formation and osteoclastic resorption through the use of 
parathyroid hormone receptor modulation using teriparatide (rhPTH[1–34]). 
Until recently, teriparatide has been the only approved osteoporosis treatment in which the 
major mode of action is stimulation of bone formation (anabolic) rather than suppression of 
bone resorption. The efficacy of teriparatide has important limitations related to its delayed and 
modest effects on increasing BMD at the total hip and femoral neck; and decreasing BMD at 
the distal 1/3 radius. The increase in cortical porosity that can occur may result in maladaptive 
effects on cortical bone microarchitecture (Bilezikian 2007). Abaloparatide has been evaluated 
in a number of nonclinical and clinical studies for its potential as a novel treatment for 
osteoporosis. Based on the biology of the PTH1 receptor signaling pathway, abaloparatide was 
designed to have less resorptive and hypercalcemic effects than PTH, resulting in a greater net 
anabolic effect. 
 
1.1.2. 
Study Drug Development 
 
1.1.2.1. 
Nonclinical Studies 
A comprehensive nonclinical program including dermal tolerance, dermal sensitization, and 
general toxicology studies have been conducted in multiple species (rat, guinea pig, rabbit, 
minipig and monkey) for abaloparatide-SC and is considered supportive for abaloparatide-sMTS. 
Additionally, dermal tolerance, dermal sensitization, and general toxicology studies with 
abaloparatide-sMTS are ongoing or planned. The findings from the completed studies support the 
conclusion that abaloparatide-sMTS is well tolerated, with no new significant safety risks 
identified as compared to abaloparatide-SC. Full details of the nonclinical development program 
for abaloparatide are provided in the Investigator’s Brochure (IB). 
 
1.1.2.2. 
Clinical Studies 
There are 19 completed or ongoing clinical studies which comprise the abaloparatide-SC 
(subcutaneous) and the abaloparatide-sMTS (transdermal) clinical development programs. The 
abaloparatide-SC clinical trial program consists of 11 completed clinical trials, including a large 
pivotal Phase 3 study (BA058-05-003) followed by an open-label extension (BA058-05-005). 
The abaloparatide-sMTS clinical trial program consists of 4 completed Phase 1 and Phase 2 
studies, and an ongoing Phase 1 study (BA058-05-015) to select an optimized formulation and 
dose for abaloparatide-sMTS to be used in the Phase 3 study. 

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Additional details for the completed clinical studies and the ongoing study BA058-05-015 can 
be found in the most recent IB. 
 
1.1.2.2.1. Abaloparatide-SC 
In the pivotal Phase 3 study (BA058-05-003, the ACTIVE trial), 2,463 postmenopausal 
osteoporotic women were randomized to receive daily 80 µg abaloparatide-SC (n=824), placebo 
(n=821), or teriparatide 20 µg (n=818) (rhPTH 1-34) for 18 months. In this trial, abaloparatide- 
SC and teriparatide significantly reduced the risk of new morphometric vertebral fractures, by 
86% and 80%, respectively, compared to placebo. Abaloparatide-SC significantly reduced 
nonvertebral, major osteoporotic and clinical fractures compared to placebo. Compared to 
teriparatide, abaloparatide significantly reduced major osteoporotic fractures. The Kaplan-Meier 
plots indicate an early and sustained fracture risk reduction of nonvertebral, major osteoporotic 
and clinical fractures with abaloparatide-SC treatment. Abaloparatide-SC was generally safe with 
acceptable tolerability in postmenopausal women with osteoporosis; the most common adverse 
reactions (incidence ≥ 5%) were hypercalciuria, dizziness, nausea, headache and palpitations. 
Consistent with reduced abaloparatide-SC-mediated calcium mobilization, the rates of 
hypercalcemia were lower in the abaloparatide-SC group compared to the teriparatide group. 
In the ACTIVExtend trial (BA058-05-005), subjects who were in the abaloparatide-SC or 
placebo arms were transitioned to oral alendronate 70 mg weekly. Subjects who received 
18 months of abaloparatide-SC followed by 6 months of alendronate experienced no new 
morphometric vertebral fractures from the BA058-05-005 study baseline and continued to have 
statistically significant reductions in nonvertebral, major osteoporotic, and clinical fractures 
when compared to subjects who previously received 18 months of placebo followed by 
6 months of alendronate. These results validate the osteoporosis treatment paradigm of build 
(with an anabolic agent), and then maintain and consolidate gains (with an anti-resorptive 
agent). 
Abaloparatide-SC demonstrated an increase in BMD at the lumbar spine, total hip, femoral 
neck and ultradistal radius in osteoporosis subjects, consistent with the fracture risk reduction. 
The results from the ACTIVE trial and the first 6 months of the ACTIVExtend trial, together 
with the entire data set from the abaloparatide-SC development program, support the safety and 
efficacy of abaloparatide-SC for the reduction of fractures in postmenopausal women with 
osteoporosis. 
In Study BA058-05-005, after 25 and 43 months of treatment (18 months abaloparatide, 
1-month transition, followed by 6 or 24 months of alendronate, respectively), the reductions in 
new vertebral fracture for abaloparatide/alendronate vs placebo/alendronate-treated subjects 
show long-term vertebral fracture reduction of 90% after 25 months and 84% after 43 months. 
In the ACTIVExtend trial the AEs were comparable between subjects previously treated with 
abaloparatide-SC and the previous placebo group. 
There have been no cases of osteosarcoma, osteonecrosis of the jaw or atypical femoral fracture 
in the entire abaloparatide-SC clinical development program. In non-clinical studies, a dose 
dependent incidence of osteosarcomas was seen in both male and female rats treated with 
abaloparatide- and in a positive control group treated with hPTH (1-34). 

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Overall, the clinical results of abaloparatide-SC-mediated early vertebral and nonvertebral 
fracture risk reduction and increases in BMD are consistent with the known anabolic 
mechanism of action, changes in bone turnover markers and nonclinical results. 
 
1.1.2.2.2. Abaloparatide-sMTS 
To date, several different abaloparatide-sMTS formulations have been evaluated in a total of 4 
Phase 1 studies and 1 Phase 2 study, including an abaloparatide-sMTS PBS formulation 
(abaloparatide phosphate buffered saline [PBS]) and an optimized formulation (abaloparatide 
ZnCl2∙HCl). 
The abaloparatide-sMTS PBS formulation had similar abaloparatide Cmax but lower 
abaloparatide AUC than the abaloparatide-SC 80 µg reference treatment. This abaloparatide- 
sMTS formulation was evaluated in 3 completed Phase 1 studies in healthy postmenopausal 
women (BA058-05-004, BA058-05-006 and BA058-05-008). An overview of the design of 
these studies is provided in Figure 1. These studies were conducted to evaluate the PK, safety, 
and local tolerability of different doses of abaloparatide-sMTS and to evaluate the impact of the 
application site and the duration of application (wear time) on PK, safety, and local tolerability. 
A Phase 2, dose-range-finding study, Study BA058-05-007, was also conducted with the 
abaloparatide-sMTS PBS formulation to evaluate the PK, efficacy, and safety of 3 doses of 
abaloparatide-sMTS (50, 100, and 150 μg) compared to 80 μg abaloparatide-SC and placebo- 
sMTS in postmenopausal women with osteoporosis. An overview of the study design is 
provided in Figure 1. The results from this study did not support the selection of this 
abaloparatide-sMTS PBS formulation for further clinical development, although it did provide 
important insights into the exposure-response relationship between abaloparatide-sMTS and 
increases in BMD. 
BA058-05-015 was a Phase 1 study initiated to select an optimized formulation and dose for 
abaloparatide-sMTS to be used in the Phase 3 study. From the pharmacokinetic data in this 
clinical study, it was determined that abaloparatide-sMTS Formulation W-1 (Abaloparatide: 
ZnCl2 
, HCl 
) 300 µg applied to the thigh for 5 minutes provides a 
single patch administration option with a similar PK profile (slow absorption with a similar 
time of maximum observed plasma concentration [tmax] and AUC) to abaloparatide-SC 80 µg 
and is expected to produce similar pharmacodynamic effects on BMD as the marketed 
abaloparatide-SC 80 µg treatment in the clinical setting. Additionally, abaloparatide-sMTS 
Formulation W-1 300 µg applied to the thigh for 5 minutes had an acceptable safety profile in 
the BA058-05-015 study. 
Full details of the results of clinical trials conducted with abaloparatide-SC and 
abaloparatide-sMTS are provided in the IB. 
 
1.2. 
Study Rationale 
The purpose of this study is to evaluate the ability of subjects to self-administer 300 µg 
abaloparatide-sMTS over a period of 29 days based on analyses of pharmacokinetic (PK) and 
pharmacodynamic (PD) markers. The systemic exposure will be compared to historical 
exposure after treatment with abaloparatide SC as well as results from BA058-05-015, 

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Cohort 7, where subjects were treated with the same product as a single dose by a trained 
healthcare professional. 
 
1.3. 
Dose Rationale 
The dose of 300 μg of abaloparatide-sMTS, applied to the thigh for 5 minutes, was chosen 
based primarily on the comparability of its pharmacokinetic profile to that of the approved 
drug abaloparatide SC at 80 µg per day as was demonstrated in study BA058-05-015. 

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2. 
STUDY OBJECTIVES AND ENDPOINTS 
2.1. 
Objective 
The primary objective of this study is to evaluate the ability of subjects to self-administer 300 µg 
abaloparatide-sMTS over a period of 29 days based on pharmacokinetic (PK) and 
pharmacodynamic (PD) markers. 
 
2.2. 
Primary Endpoint 
The primary endpoint is the systemic exposure of the drug at Day 1, Day 15 and Day 29. 
2.3. 
Secondary Endpoints 
2.3.1. 
Pharmacodynamic (PD) Endpoints 
• Percent change of s-PINP from baseline to Day 15 and Day 29. 
• Change and percent change in serum calcium (albumin-corrected) from baseline to 
each post-dose timepoint. 
• Change and percent change in serum phosphorus from baseline to each post-dose 
timepoint. 
• Change and percent change in cAMP from baseline to each post-dose timepoint. 
2.3.2. 
Other Endpoints 
• Subject satisfaction and convenience of treatment as measured by Treatment 
Satisfaction Questionnaire for Medication (TSQM9) at Day 15 and Day 29 
• Subject acceptability measurement (5-point Likert Scale) at Day 1, Day 15 and 
Day 29 
• Subject preference for treatment attributes at Day 1, Day 15 and Day 29 
• Investigator assessment of signs of local skin reaction using a 4-point scale at Day 1, 
Day 15 and Day 29 
• Subject assessment of symptoms of local skin reaction using a 4-point scale from Day 
1 through Day 29 as recorded in the subject diary 
• Daily measurement of user errors as recorded in the subject diary 
• Daily measurement of patch adhesion as recorded in the subject diary. 
2.3.3. 
Safety and Tolerability Endpoints 
AEs, vital signs (orthostatic blood pressure, pulse rate, body temperature, and respiration rate), 
ECG, and laboratory tests (serum chemistry, hematology, coagulation, and urinalysis) will be 
assessed as per the schedule of assessment (SOA) (Table 1). 

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3. 
STUDY DESIGN 
3.1. 
Description of the Study Design 
This is an open-label study to evaluate the usability of the abaloparatide-sMTS by subjects with 
low BMD. The study will consist of a Screening Period (up to 2 months), a Pre-Treatment Period 
(1 week), a Treatment Period (1 month), and a 1 week Follow-Up after the last dose of study 
medication. Thus, subjects will be in the study for up to 4 months. Eligible subjects will undergo 
protocol specified procedures, including BMD (if dual energy x-ray absorptiometry [DXA] was 
done over 12 months prior to Screening) and bone turnover marker assessment. For the purpose 
of this study, 1 month is equivalent to 30 days. 
All eligible subjects will be provided calcium and vitamin D to ensure that their daily intake is 
1,200 mg/day and 800 IU/day, respectively, or a dose determined by the Investigator and 
agreed by the Sponsor Medical Monitor, according to the subject’s need. 
All subjects will undergo safety, pharmacokinetic, bone turnover marker (s-PINP), and 
assessments of User Errors and Subject Preference Outputs according to the SOA (Table 1). The 
study design is presented in Figure 1, below. 
Figure 1: 
Study Design 
 
 
 

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4. 
SELECTION OF STUDY POPULATION 
In order to participate in this study, a subject must meet all of the following inclusion criteria and 
none of the exclusion criteria. Subjects who were screened and excluded from this study will be 
recorded in the eCRF with the reason for the screen failures. 
4.1. 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria: 
1. Healthy ambulatory female from 50 to 85 years of age (inclusive). 
2. Postmenopausal for at least 2 years. Postmenopausal status will be established by a history of 
amenorrhea for at least 2 years, negative serum pregnancy test or an elevated serum follicle- 
stimulating hormone (FSH) value of ≥ 30 IU/L. 
3. BMD T-score based on the female reference range of <-1.0 and >-5.0 at the lumbar spine 
(L1–L4) or hip (femoral neck or total hip) by DXA. Note: Every effort will be made to enroll 
subjects with a T-score of -2.0 or lower but > -5.0; for those with scores higher than -2.0, 
preference should be given to subjects with lower BMD scores. 
4. Good general health as determined by medical history and physical examination (including 
vital signs), has a body mass index of up to 33 kg/m2, and is without evidence of clinically 
significant abnormality that may increase the risk associated with study participation or 
investigational product administration, or may interfere with compliance or the interpretation 
of study results, and would make the subject inappropriate for this study in the opinion of the 
Investigator 
5. Serum calcium (albumin-corrected), intact PTH, serum phosphorus, alkaline phosphatase, and 
thyroid stimulating hormone (TSH) values all within the normal range during the Screening 
Period. Subjects with minor elevations or reductions in serum calcium may be enrolled if 
serum ionized calcium is normal. Any subject with an elevated alkaline phosphatase value, 
and who meets all other entry criteria would be required to have a normal bone-specific 
alkaline phosphatase to be enrolled 
6. Serum 25-hydroxyvitamin D values ≥ 20 ng/mL. 
7. Resting 12-lead electrocardiogram at screening shows no clinically significant abnormality. 
8. Systolic blood pressure is ≥ 100 and ≤ 155 mmHg, diastolic blood pressure is ≥ 40 and 
≤ 95 mmHg, and heart rate is ≥ 45 and ≤ 100 bpm (taken sitting) 
9. No clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells, and 
platelets, or usual serum chemistry, including electrolytes, renal function, liver function and 
serum proteins, that might be expected to interfere with the subject’s health and/or medical 
treatment during the study 
10. Read, understood, and signed the written informed consent form 
11. Hemoglobin value ≥ 12.0 g/dL 

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4.2. 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria will be excluded from the study: 
1. History of bone disorders (eg, Paget’s disease) other than postmenopausal osteoporosis 
2. History of prior external beam or implant radiation therapy involving the skeleton, other than 
radioiodine 
3. History of Cushing’s disease, hypo- or hyper-parathyroidism or malabsorptive syndromes 
within the past year 
4. History of significantly impaired renal function (serum creatinine > 177 μmol/L or 
> 2.0 mg/dL). If serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated creatinine 
clearance (Cockcroft-Gault) must be ≥ 37 mL/min 
5. History of any cancer within the past 5 years (other than basal cell or squamous cancer of the 
skin) 
6. History of osteosarcoma at any time 
7. History of nephrolithiasis or urolithiasis within the past 5 years 
8. Application site (thigh) compromised by scars, inflammation or skin conditions to an extent 
that may compromise uniformity of abaloparatide-sMTS application or drug delivery (nevi, 
plaques, tattoos, scars, piercing, etc.) 
Medication-related exclusion criteria: 
9. Known history of hypersensitivity to any of the test materials or related compounds 
10. Prior therapeutic treatment with PTH- or PTHrP-derived drugs, or bone anabolic drugs 
including abaloparatide, teriparatide, or PTH(1-84). Subjects who received abaloparatide in 
prior Phase 1 studies are not excluded 
11. Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within 
the past year (12 months). Subjects who have received a short course of oral bisphosphonate 
therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more 
months prior to enrollment 
12. Treatment with fluoride or strontium in the past 5 years or prior treatment with gallium nitrate 
or bone-acting investigational agents at any time 
13. Prior treatment with calcitonin or tibolone in the past 6 months 
14. Treatment with denosumab within the past 18 months 
15. Treatment with anticonvulsants that affect vitamin D metabolism (phenobarbital, phenytoin, 
carbamazepine or primidone) or with chronic heparin within the 6 months prior to the 
Screening Period 
16. Treated with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus) within the 
past 90 days. 

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17. Prior treatment with selective estrogen receptor modulators (except hormone replacement 
therapy) or daily treatment with oral, intranasal, or inhaled corticosteroids within the 
12 months prior to the Screening Period. Occasional use of all corticosteroids (for seasonal 
allergies or asthma) is not exclusionary. Use of low dose oral corticosteroids (eg, ≤ 5 mg/day 
of prednisone or the relative equivalent dose of another corticosteroid) is also not 
exclusionary. 
18. Participation in another clinical trial with any investigational drug or device within 3 months 
or 5 half-lives of the investigational drug (if known), whichever is longer, of study drug 
administration. 
Lifestyle-related exclusion criteria: 
19. Abnormal nutritional status as assessed by the investigator including abnormal diets and 
excessive or unusual vitamin or herbal intakes; vitamin D intake of ≥ 4,000 IU/day or vitamin 
A intake of ≥ 10,000 IU/day. Short term use of high doses of vitamin D to bolster endogenous 
vitamin D levels for study entry during the screening period is not exclusionary 
20. Active drug or alcohol dependence or abuse (excluding tobacco or medicinal or recreational 
marijuana use where legal unless there is evidence of abuse) within 12 months of the 
screening period; or evidence of such abuse (in the opinion of the investigator). 
 
4.3. 
Subject Withdrawal or Termination 
4.3.1. 
Reasons for Withdrawal or Termination 
Subjects will be informed that they have the right to withdraw from the study at any time for any 
reason without prejudice to their medical care. 
The Investigator may consider discontinuing subjects from the study for the following reasons: 
• Severe hypersensitivity to abaloparatide or test materials 
• Refusal of treatment 
• Inability to complete study procedures 
• Lost to follow-up 
• Adverse events or laboratory abnormalities which, in the judgment of the 
Investigator, justifies treatment cessation 
• Serious intercurrent illness 
• Protocol violations 
• Administrative reasons 
• Incident vertebral or non-vertebral fragility fracture 

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4.3.2. 
Handling of Subject Withdrawals or Terminations 
If a subject is withdrawn or discontinued from the study, the reason for withdrawal from the study 
must be recorded in the source documents and on the case report form. All subjects withdrawn 
prior to completing the study should be encouraged to complete study procedures scheduled for 
the Visit 5 / end of treatment (EOT) (Day 29) visit as soon as possible. All AEs should be 
followed as described in Section 7. Subjects who discontinue or are withdrawn from the study 
will not be replaced. Whenever a subject is discontinued prematurely, the Sponsor and the 
Medical Monitor must be notified. 
4.4. 
Concomitant Medications 
Subjects will be provided with calcium and vitamin D supplements to be administered daily from 
the Pretreatment Period until the end of the Treatment Period. The supplement dose will be 
determined by the Investigator and agreed by the Sponsor Medical Monitor, according to the 
subject’s need to ensure that their daily intake of calcium and vitamin D is 1,200 mg/day and 800 
IU/day, respectively. The doses and schedule of calcium and vitamin D supplements should be 
adhered to and not be changed other than for medical necessity. The supplements should be taken 
as instructed by the Investigator. 
For any required concomitant medication, such as statins or antihypertensives, the subject must 
be on a stable dose for 90 days prior to the first treatment visit (Day 1) and every effort should be 
made to maintain a stable dose during study participation. 
The occasional use of over-the-counter medications at approved doses (eg, ibuprofen or 
acetaminophen) for headache or minor discomfort is allowed. These are to be recorded on the 
appropriate case report form. Subjects should not take any other medications, including over-the- 
counter medications, herbal medications, or mega-doses of vitamins during the study without the 
prior approval of the Investigator. 
If it becomes necessary for a subject to take any other medication during the study, the specific 
medication(s) and indication(s) must be discussed with the Investigator. All concomitant 
medications taken during the course of the study must be recorded in the subject’s medical record 
or source document and transcribed into the eCRF. 
4.5. 
Prohibited Medications 
Please refer to Section 4.2 for medication related exclusion criteria. 
Subjects should not take any other medications, including over-the-counter medications, herbal 
medications, or mega-doses of vitamins during the study without prior approval of the 
Investigator. The occasional use of over-the-counter medications (eg, ibuprofen or 
acetaminophen) for headache or minor discomfort will be allowed if discussed with the 
Investigator, recorded in the source documents, and in the subject’s eCRF. 
Use of corticosteroids for seasonal allergies or asthma is not prohibited. Use of low dose oral 
corticosteroids (eg, ≤ 5mg/day of prednisone or the relative equivalent dose of another 
corticosteroid) is also not exclusionary. Subjects who require chronic treatment with either an 
anticonvulsant (phenobarbital, phenytoin, carbamazepine or primidone), or with heparin will be 
discontinued. 

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4.6. 
Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification documenting the reason for study suspension or 
termination will be provided by the suspending or terminating party to the principal investigator, 
and regulatory authorities. If the study is prematurely terminated or suspended, the principal 
investigator will promptly inform the Institutional Review Board (IRB) and will provide the 
reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to subjects. 
• Insufficient compliance with protocol requirements. 
• Data that are not sufficiently complete and/or evaluable. 
• Decision of Sponsor. 
Study may resume once concerns about safety, protocol compliance or data quality are addressed 
and satisfy the Sponsor, IRB and/or Regulatory Agencies, if applicable. 
4.7. 
Temporary Suspension of Treatment 
Due to the short nature of the study, temporary suspension of treatment is not an option for the 
Investigator. Any subject that is deemed inappropriate for continuing treatment will be withdrawn 
from the study and the reason will be noted in the CRF. 

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5. 
STUDY DRUG ADMINISTRATION AND MANAGEMENT 
5.1. 
Study Medication 
All study medications are for investigational use only and are to be used only within the context 
of this study, and administration of treatment is to be carried out as described in Section 5.5. 
Abaloparatide-sMTS will be supplied to the study site by RADIUS. 
5.1.1. 
Abaloparatide-sMTS 
The abaloparatide-sMTS is enclosed in a collar assembly for loading onto a spring-loaded 
applicator. The abaloparatide-sMTS dose will be 300 µg. 
Abaloparatide-sMTS is stored refrigerated at 2º to 8ºC (36º to 46ºF). The abaloparatide-sMTS 
will be removed from refrigeration approximately 1 hour prior to application. Please refer to the 
pharmacy manual for further details. 
5.2. 
Packaging, Labeling and Storage 
5.2.1. 
Packaging and Labeling 
Abaloparatide-sMTS and applicators will be supplied to the study site by RADIUS. All 
packaging operations will be performed in accordance with Good Manufacturing Practices. 
All study drugs will be labeled with a caution statement and other information required by local 
Regulatory Authorities. 
5.2.2. 
Storage 
All study medications (abaloparatide-sMTS) must be kept in a secure, limited-access storage area 
at 2° to 8°C (36° to 46°F) until dispensed for dosing or until returned to the Sponsor. 
For Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/EOT), when the product is applied 
during a clinic visit, the used arrays will be carefully placed in a supplied container using minimal 
manipulation and frozen for returning to the manufacturer for further inspection and analysis 
according to a supplied handling procedure manual. Refer to the pharmacy manual for additional 
details. 
Calcium and vitamin D supplements should be stored according to the manufacturer 
recommendations on the bottle. 
5.3. 
Study Medication Administration 
Subjects will be encouraged to drink 8 ounces of water 1 to 2 hours prior to dosing. 
Prior to the administration of study drug, the application site will be prepped and cleaned with an 
alcohol wipe, allowed to air dry, and then examined in order to assure that the area is not 
compromised. Each application site will be graded according to a 4-point scale by the investigator 
to assess signs of local skin reactions (at clinic visits; Section 6.6.2.1) and by the subject to assess 
symptoms of local skin reactions (each day during the treatment period; Section 6.6.2.2), prior to 
abaloparatide-sMTS application, immediately after removal of abaloparatide-sMTS, and at 1 hour 
after abaloparatide-sMTS application. For any severe local skin reactions, evaluations by the 

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subject will continue at 24 hour intervals until the reaction has stabilized or resolved (see 
Section 6.6.2.2). 
Before initial use of abaloparatide-sMTS, the subject will be trained on the Instructions for Use 
and will demonstrate their ability to self-administer the abaloparatide-sMTS with the Investigator 
present. During subsequent applications, the subject will follow the Instructions for Use. It is 
important to note that if any component is damaged, the subject is to be instructed to replace the 
abaloparatide-sMTS patch with a new one and place the damaged patch in a container that was 
provided and to bring this together with the other used and unused abaloparatide-sMTS at the 
next clinic visit. Please refer to the pharmacy manual for additional details. 
5.4. 
Treatment Assignment 
All subjects who sign informed consent and continue to meet eligibility criteria for the study will 
be treated with abaloparatide-sMTS. 
5.5. 
Dosing and Administration 
The first self-administration of abaloparatide-sMTS will occur at the study site on Day 1, under 
observation. 
Subjects will be trained by study personnel to self-administer study medication with the 
abaloparatide-sMTS patch and applicator; a single daily dose of 300 µg of abaloparatide-sMTS 
will be applied to the thigh for 5 minutes during the treatment period following the Instructions 
for Use. Please refer to the pharmacy manual for additional details on study drug administration. 
The subject is to remain under observation for a minimum of 60 minutes after abaloparatide- 
sMTS. On the days when blood sampling is required after study medication administration, the 
subject is to remain at the vicinity of the clinic for the blood collections scheduled up to 4 hours 
after abaloparatide-sMTS application. Subjects are to be instructed to self-administer abaloparatide- 
sMTS application at a location where they have the ability to sit or lie down. 
At each clinic visit during the Treatment Period, any used and unused abaloparatide-sMTS should 
be returned. 
5.6. 
Treatment Compliance 
To ensure treatment compliance, the Investigator or designee will supervise all study drug 
administration that occurs at the site. At each study visit, the Investigator or designee will review 
subject compliance with study drug administration and will remind the subject of study drug 
dosing requirements. 
Subject compliance will be ascertained by using the data entered on the subject diaries as well as 
the total used and unused abaloparatide-sMTS returned at each study visit. 
Discrepancies will be discussed with the subjects, documented in the medical charts, and 
recorded in the eCRF as appropriate. If a subject does not take the required medication or 
supplements (abaloparatide-sMTS, calcium and vitamin D), the reason for the missed dose is to 
be recorded by the subject in the subject diary. 

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5.7. 
Drug Accountability 
The Investigator or designated site staff will maintain records documenting the dates and amounts 
of the following: 
• Study drug received at the study site 
• Study drug dispensed to the subject 
• Study drug returned by the subject 
• Study drug returned to sponsor/designee or destruction of study drug on site 
Subjects will be provided with a container and instructed to return all used and unused study drug 
to the site for destruction. Study drug will be retained at the site until inventoried by the study 
monitor and approved for destruction or return. The study monitor will verify study drug records 
and inventory throughout the study. 

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6. 
STUDY PROCEDURES AND SCHEDULE 
6.1. 
Study Procedures 
6.1.1. 
Study Specific Procedures 
The study-specific assessments are detailed in this section and outlined in Table 1. At Screening, 
any results falling outside of the reference ranges may be repeated 1 time at the discretion of the 
Investigator. 
6.2. 
Study Schedule 
This study is comprised of 5 clinic visits with either a sixth visit or telephone call for Follow-up. 
Study assessments are to be performed according to the SOA (Table 1). There is a ± 2-day 
window for each clinic visit. 
The study will consist of a Screening (up to 2 months), a Pre-treatment Period (1 week), a 
Treatment Period (29 days) and a Follow-up Period (7 days). During the Treatment Period, 
subjects will have clinic visits for study-related protocol procedures at Day 1, Day 15 and 
Day 29. The Treatment Period of the study will be considered complete when the last subject 
completes the last clinic visit. 
6.2.1. 
Schedule of Assessments and Procedures 
A comprehensive schedule for assessments and procedures is presented in the SOA (Table 1). 

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Table 1: 
Schedule of Assessments 
 
Procedure 
Study Visit 
1 
2 
Treatment Period 
6 
3 
4 
5 
Visit Day 
Screening 
(-67 to -8) 
Pre- 
Treatment 
(-7 to -1) 
Day 1 
Day 15 
Day 29 / End of 
Treatment 
(EOT) 
Day 36 
(Follow-up) 
Visit 
Window 
(Days) 
N/A 
± 2 
± 2 
± 2 
± 2 
± 2 
Informed consent 
X 
Verification of entry criteria 
X 
Physical examination1 
X 
Review of medical history2 
X 
Symptom directed physical 
examination1 
X 
X 
X 
X 
Vital signs3 
X 
X 
X 
X 
Weight measurement 
X 
X 
X 
X 
X 
Height measurement4 
X 
ECG5 
X 
X 
X 
X 
Urinalysis (dipstick)6 
X 
X 
X 
X 
Chemistry blood collection7 
X 
X 
X 
X 
Serum calcium, albumin, 
phosphorus8 
X 
X 
X 
Cyclic AMP9 
X 
X 
X 
24 hour urine collection (for 
calcium:creatinine and 
creatinine clearance)10 
X 
Hematology7 
X 
X 
X 
X 
Coagulation (PT and PTT) 
blood collection 
X 
PTH (intact) 
X 
25-hydroxyvitamin D level 
X 
1,25-dihydroxyvitamin D 
level 
X 
Estradiol, FSH 
X 
Serum pregnancy 
X 
Thyroid stimulating hormone 
X 
Urine Drug and Alcohol Test11 
X 
X 
Subject training on study drug 
administration, completion of 
subject diary and assessment 
of symptoms of local skin 
reactions12 
X 
Dispensing of calcium and 
vitamin D supplements 
X 
X 
X 
Study drug administration13 
Every day between Visit 3 and Visit 5, inclusive 
Collect used abaloparatide- 
sMTS and swab for residual 
drug and swab residuals 
X 
X 
X 
BMD of lumbar spine, total 
hip and femoral neck by DXA 
14 
X 
Investigator assessment of 
signs of local skin reaction15 
X 
X 
X 

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Procedure 
Study Visit 
1 
2 
Treatment Period 
6 
3 
4 
5 
Visit Day 
Screening 
(-67 to -8) 
Pre- 
Treatment 
(-7 to -1) 
Day 1 
Day 15 
Day 29 / End of 
Treatment 
(EOT) 
Day 36 
(Follow-up) 
Visit 
Window 
(Days) 
N/A 
± 2 
± 2 
± 2 
± 2 
± 2 
Subject assessment of 
symptoms of local skin 
reaction16 
Every day between Visit 3 and Visit 5, inclusive 
X23 
Subject assessment of patch 
adhesion17 
Every day between Visit 3 and Visit 5, inclusive 
Subject assessment of pain18 
Every day between Visit 3 and Visit 5, inclusive 
Subject assessment of user 
errors 
Every day between Visit 3 and Visit 5, inclusive 
Assessment of subject 
preferences for treatment 
attributes 
X 
X 
X 
Assessment of subject 
convenience and satisfaction 
(TSQM9) 
X 
X 
Assessment of subject 
acceptability (5-point Likert 
scale) 
X 
X 
X 
Subject diary review19 
X 
X 
X24 
Document AEs and 
concomitant medication20 
After signing informed consent until follow up visit 
PK draw21 
X 
X 
X 
Serum marker of bone 
metabolism (s-PINP) 22 
X 
X 
X 
Drug supply / Drug re-supply 
X 
X 
Drug Accountability 
X 
X 
1. A complete physical examination includes a review of the following systems: head/neck/thyroid, eyes/ears/nose/throat, respiratory, 
cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological. Breast, anorectal, and genital examinations will 
be performed when medically indicated. After screening, any clinically significant abnormal findings from the symptom-directed 
physical examinations should be reported as AEs. 
2. Including alcohol and tobacco use assessment. 
3. Blood pressure, pulse rate, body temperature, and respiration rate are to be recorded predose at each study visit. Only blood 
pressure, pulse rate and respiration rate are to be recorded 1 hour after abaloparatide-sMTS application at each study visit during 
the treatment period. All blood pressure assessments will be orthostatic. Pulse rate will also be obtained at 15 minutes after 
abaloparatide-sMTS application at Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/EOT). 
4. Height is to be measured at the screening visit/ Visit 1 in the standing position using a medical stadiometer. 
5. During the Treatment Period, ECGs are to be performed predose after 5 minutes of rest and prior to any blood draw, and 1 hour 
after abaloparatide-sMTS application on Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/EOT). 
6. All routine urinalysis will be performed on a sample freshly voided during the visit and sent to a local laboratory for microscopy 
if test is positive for micro-organisms via dipstick. 
7. Blood draw for serum chemistry and hematology will be done during the Screening (Visit 1) and at predose on Day 1 (Visit 3), 
Day 15 (Visit 4) and Day 29 (Visit 5/EOT). 
8. Blood draw for serum calcium, albumin and phosphorus will be done at predose and at 4 hours after abaloparatide-sMTS 
application on Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/EOT). 
9. Blood draw for cAMP taken predose and at 30 minutes after abaloparatide-sMTS application on Day 1 (Visit 3), Day 15 (Visit 4) 
and Day 29 (Visit 5/EOT). 
10. A 24 hour urine collection will start on Day -8 and complete on the day of the pre-treatment visit (Day -7). 
11. All subjects will have a urine drug screen for drugs of abuse and alcohol performed on the Screening Period (Visit 1), and on 
Day 1 (Visit 3). 
12. When necessary, re-training may be done post Day 1 / Visit 3. 
13. Study drug is self-administered daily beginning Day 1 (Visit 3) through Day 29 (Visit 5/EOT), inclusive. On Days 1, 15, and 29, 
subject will self-administer abaloparatide-sMTS at the study site. 

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14. BMD measured by DXA at Screening visit if most recent DXA was done over 12 months prior to screening. 
15. Investigators will perform an assessment of the application site at each clinic visit prior to application of abaloparatide- 
sMTS, 5 minutes after application (ie, immediately upon removal of the patch), and 1- hour following abaloparatide- 
sMTS application. Signs of local skin reactions will be assessed using a 4-point scale, as described in Section 6.6.2.1. 
16. The subject will maintain a diary to record their assessment of symptoms of local skin reactions for 29 days beginning on Day 1 
(Visit 3). The subject will evaluate the application site prior to study drug administration, 5 minutes after application (ie, 
immediately upon removal of abaloparatide-sMTS), and 1 hour after abaloparatide-sMTS application. Symptoms of local skin 
reactions will be assessed using a 4-point scale as described in Section 6.6.2.2. 
17. Subject assessment of patch adhesion immediately prior to abaloparatide-sMTS removal on each day of the treatment period 
from Day 1 (Visit 3) to Day 29 (Visit 5/EOT). 
18. An assessment of pain (separate from the pain question on the 4-point scale for local tolerance) will be done after sMTS 
application. 
19. The Subject Diary will be reviewed by study personnel at each study visit to ensure subject compliance. 
20. AEs and SAEs will be recorded on the case report forms starting from the signing of the informed consent until 7 days after the 
last dose of study medication. All treatment-related AEs will be followed until resolution or stabilization. Any SAEs that occur 
at any time after completion of the study, which are considered by the investigator to be related to study treatment, must be 
reported to the Sponsor or its designee. 
21. Blood samples for measurement of plasma concentrations of abaloparatide will be taken at Day 1 (Visit 3), Day 15 (Visit 4) and 
on Day 29 (Visit 5/EOT). The pharmacokinetic measurements will be assessed predose and at 10 minutes, 20 minutes, 
30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after abaloparatide-sMTS application. 
22. Blood samples for s-PINP taken within 1-hour prior to dosing on Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/EOT). 
23. Assessed only for subjects with signs or symptoms of local skin reactions ongoing as of Day 29. 
24. Subject will return diary to study site. 

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6.2.2. 
Informed Consent Process 
Each subject must sign and date a study-specific informed consent form (ICF) before any study 
specific procedures can be performed. The consent forms will comply with all applicable 
regulations governing the protection of human subjects. An ICF, approved by the sponsor and 
the site’s IRB must be used. The Investigator or designee must record the date when the ICF was 
signed in the subject’s source document. 
6.2.3. 
Assigning Subject Numbers 
A unique subject number will be assigned to each subject on Day 1. The subject number will be 
used as the primary subject identifier for the remainder of the study. 
6.2.4. 
Subject and Disease Characteristics 
Subject and disease characteristics include the following: demographics, medical history, height, 
and weight. 
Medical history will be elicited from each subject during screening. Based on the medical 
history, the subject will be assessed for any disqualifying medical conditions as specified in the 
inclusion and exclusion criteria. The medical history shall include a complete review of systems, 
past medical and surgical histories, and any allergies. 
6.2.5. 
Screening Period (Visit 1; Days -67 to -8) 
Signed informed consent will be obtained and eligibility for study entry assessed. The following 
baseline screening evaluations will be performed: 
• Obtain informed consent 
• Verify subject eligibility 
• Comprehensive physical examination 
• Review of medical history, including alcohol, tobacco, and drug use 
• Review of concomitant medications 
• Orthostatic blood pressure and vital signs 
• Height 
• Weight 
• 12 Lead ECG; subjects should be allowed to rest for 5 minutes preceding each ECG 
• Urine dipstick 
• Urine drug and alcohol test. The urine will be tested for the following drugs: 
amphetamines, barbiturates, benzodiazepines, cocaine, ethanol, methadone, opiates, 
phencyclidine, propoxyphene, and a marijuana screening test. 
• Blood draw for serum chemistry, hematology 
• Blood draw for coagulation testing: PT and PTT 
• Blood draw for serum pregnancy (if needed) 
• Blood draw for intact PTH, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D level 
• Blood draw for estradiol, FSH and TSH level 
• BMD assessments of lumbar spine, total hip and femoral neck by DXA (if not available 
from the previous 12 months) 
• Provide subject instructions for the 24 hour urine collection to be collected beginning 
Day -8 during the pre-treatment period 

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Subjects who do not meet the 25-hydroxyvitamin D entry criterion may receive vitamin D 
supplementation and be retested. Similarly, subjects with minor elevations of PTH may be 
retested 1 time after vitamin D supplementation. Subjects whose laboratory tests do not fall 
within the specified ranges as detailed in the inclusion/exclusion criteria may have the samples 
redrawn and the tests repeated once during the screening period. 
 
Although the Screening Period is 60 days, all enrolled subjects must have the following safety laboratory 
results reported within 30 days prior to Day 1 (Visit 3): hematology, serum chemistry (including calcium 
and phosphorus), urinalysis, PTH (intact), 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, and serum 
pregnancy. These laboratory tests must be repeated for subjects who were screened more than 30 days 
prior to Day 1 (first day of treatment). A list of the laboratory tests can be seen in Table 2 
Adverse events will be recorded for each subject from the time of signing of the informed 
consent. 
 
6.2.6. 
Pre-treatment Period (Days -7 to -1) 
Subjects who are eligible for the study, on the basis of screening evaluations, will enter the 7-day 
Pre-treatment period of the study. 
• Symptom directed physical examination 
• Dispense calcium and vitamin D to ensure that daily intake is 1,200 mg/day and 800 
IU/day, respectively, (doses to be determined by the Investigator and agreed upon by the 
Sponsor Medical Monitor, according to the subject’s need) 
• A 24-hour urine sample will be collected. Subjects will discard the 1st void and begin a 
24-hour urine collection on the day prior to the clinic visit 
• AE and concomitant medications review 
6.2.7. 
Treatment Period 
During the Treatment Period, subjects will self-administer a single dose of study medication 
once a day. 
At each clinic visit during this period, recent health status will be obtained, the subject diary 
reviewed, AEs collected and orthostatic blood pressure and vital signs recorded. Laboratory 
assessments of chemistry, hematology and urinalysis will be obtained at Day 1 (Visit 3), Day 15 
(Visit 4) and Day 29 (Visit 5/EOT). 
Bone turnover marker assessments (s-PINP) will be performed within 1-hour prior to the 
application of abaloparatide-sMTS on Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5/ 
EOT). Results for these labs will not be required prior to dosing. 
6.2.7.1. 
Visit 3 (Day 1) 
The following assessments will be conducted on Day 1: 
• Symptom directed physical examination 
• Body temperature taken predose; orthostatic blood pressure and vital signs: BP, pulse and 
respiratory rate taken predose and 1-hour after abaloparatide-sMTS application; pulse 
rate 15 minutes after abaloparatide-sMTS application 
• Weight 

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• 12-lead ECG, to be taken predose and at 1-hour after abaloparatide-sMTS application. 
Subjects should be allowed to rest for 5 minutes preceding each ECG 
• Urine dipstick test on urine sample taken predose 
• Urine drug and alcohol test 
• Blood draw for serum chemistry and hematology taken predose 
• Blood draw for s-PINP taken up to 1-hour predose 
• Blood draw for cAMP at predose and at 30 minutes after abaloparatide-sMTS application 
• Training on use of the abaloparatide-sMTS 
• Subject self-administers abaloparatide-sMTS under the observation of the Investigator 
• Blood draw for serum calcium, albumin and phosphorus at predose and 4 hours after 
abaloparatide-sMTS application 
• PK draw done predose and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 
2 hours, 3 hours, and 4 hours after abaloparatide-sMTS application 
• Collect used abaloparatide-sMTS and swab for measurement of residual drug 
• AE and concomitant medication review 
• Dispense study medication 
• Dispense calcium and vitamin D supplements 
• Investigator assessment of signs, and subject assessment of symptoms, of local skin 
reactions at predose, 5 minutes after application (ie, immediately upon removal of 
abaloparatide-sMTS), and 1-hour following abaloparatide-sMTS application. For any 
local skin reactions that persist 1 hour after abaloparatide-sMTS application, evaluations 
by the subject will continue at 24 hour intervals until the skin irritation has stabilized or 
resolved. 
• Prior to dosing, instruct subject on completion of subject diary, including subject 
assessment of local skin reactions, patch adhesion, pain, and user errors. This will need to 
be done daily for 29 days beginning on Visit 3 (Day 1). 
• Collection of subject preference for treatment attributes and acceptability (5-point Likert 
scale) information 
• Subject assessment of pain 
• Subject assessment of patch adhesion immediately prior to abaloparatide-sMTS removal 
6.2.7.2. 
Visit 4 (Day 15) 
The following assessments will be conducted on Day 15: 
• Symptom driven physical examination 
• Body temperature taken predose; orthostatic blood pressure and vital signs: BP, pulse and 
respiratory rate taken predose and 1 hour after abaloparatide-sMTS application; pulse rate 
15 minutes after abaloparatide-sMTS application 
• 12-lead ECG, to be taken predose and at 1 hour after abaloparatide-sMTS application. 
Subjects should be allowed to rest for 5 minutes preceding each ECG 
• Weight 
• Urine dipstick test on urine sample taken predose 
• Blood draw for serum chemistry and hematology taken predose 
• Blood draw for s-PINP within 1 hour prior to application of abaloparatide-sMTS 

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• Blood draw for serum calcium, albumin and phosphorus at 4 hours after abaloparatide- 
sMTS application 
• Blood draw for cAMP at predose and at 30 minutes after abaloparatide-sMTS application 
• PK draw done predose and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 
hours, 3 hours, and 4 hours after abaloparatide-sMTS application 
• Subject self-administration of abaloparatide-sMTS 
• Collect used abaloparatide-sMTS and swab for measurement of residual drug 
• AE and concomitant medication review 
• Drug accountability 
• Dispense study medication 
• Dispense calcium and vitamin D supplements 
• Investigator and Subject assessment of local skin reactions predose, 5 minutes after 
application (ie, immediately upon removal of abaloparatide-sMTS), and 1 hour following 
abaloparatide-sMTS application. For any administration site reaction, evaluations by the 
subject will continue at 24 hour intervals until the skin irritation has stabilized or 
resolved. 
• Subject assessment of patch adhesion immediately prior to abaloparatide-sMTS removal 
• Subject assessment of pain 
• Subject assessment of user error 
• Collection of subject preference for treatment attributes, acceptability (5-point Likert 
scale) and convenience and satisfaction (TSQM9) information 
• Review subject diary 
6.2.7.3. 
Visit 5 / End of Treatment (Day 29) 
The following assessments will be conducted on Day 29: 
• Symptom driven physical examination 
• 12-lead ECG, to be taken predose and at 1 hour after abaloparatide-sMTS application. 
Subjects should be allowed to rest for 5 minutes preceding each ECG 
• Body temperature taken predose; orthostatic blood pressure and vital signs: BP, pulse 
and respiratory rate taken predose and 1 hour after abaloparatide-sMTS application; pulse 
rate taken 15 minutes after abaloparatide-sMTS application 
• Weight 
• Urine dipstick test on urine sample taken predose 
• Blood draw for serum chemistry and hematology taken predose 
• Subject self-administration of abaloparatide-sMTS 
• Blood draw for serum calcium, albumin and phosphorus at 4 hours after abaloparatide- 
sMTS application 
• Blood draw for cAMP at predose and at 30 minutes after abaloparatide-sMTS application 
• PK draw done predose and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 
2 hours, 3 hours and 4 hours after abaloparatide-sMTS application. 
• Collect used abaloparatide-sMTS and swab for measurement of residual drug 
• AE and concomitant medication review 
• Drug accountability 

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• Bone turnover markers (s-PINP) taken within 1 hour prior to abaloparatide-sMTS 
application 
• Investigator and subject assessment of local skin reactions predose, 5 minutes after 
application (ie, immediately upon removal of abaloparatide-sMTS), and 1 hour following 
study drug administration. For any administration site reaction, evaluations by the subject 
will continue at 24 hour intervals until the skin irritation has stabilized or resolved. 
• Subject assessment of patch adhesion immediately prior to abaloparatide-sMTS removal 
• Subject assessment of pain 
• Subject assessment of user error 
• Collection of subject preference for treatment attributes, acceptability (5-point Likert 
scale) and convenience and satisfaction (TSQM9) information 
• Review subject diary 
6.2.8. 
Visit 6/Follow up (Day 36) 
Visit 6/ Follow up (Day 36) can be completed as a clinic visit or remotely through a phone call 
by the study staff. The following are the study assessments for Visit 6: 
• Assessment of local tolerance post EOT visit for subjects with ongoing signs or 
symptoms of local skin reactions 
• AE and concomitant medication review 
6.2.9. 
Unscheduled Visit 
If the subject returns to the clinic for an unscheduled visit (eg, to follow-up on an abnormal 
laboratory test), the procedures performed at this visit will be recorded in the eCRF and source 
documentation. 
6.3. 
Vital Signs and Physical Examinations 
A comprehensive physical examination (review of all body systems), height, weight, and vital 
signs assessment will be performed at Screening. 
A comprehensive physical examination includes a review of the following systems: 
head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, 
skin, musculoskeletal, and neurological. Breast, anorectal, and genital examinations will be 
performed when medically indicated. After screening, any clinically significant abnormal 
findings in physical examinations should be reported as AEs. 
Height and weight will be measured with shoes off. Height is to be measured using a wall 
mounted stadiometer. 
Vital signs include orthostatic blood pressure (systolic and diastolic), temperature (oral), pulse 
rate, and respiratory rate. These will be assessed following a 5 minute rest (seated or supine). At 
visits when study drug is administered at the site, vital sign assessments will be collected before 
the dose of study drug and 1 hour after abaloparatide-sMTS application for blood pressure, pulse 
and respiratory rate. Seated or supine and standing blood pressure measurements will be 
performed at each visit during the Treatment Period. In addition, pulse rate will be collected 
15 minutes after abaloparatide-sMTS application. Temperature will only be collected predose. 

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6.4. 
12-Lead Electrocardiogram 
A standard, 12 lead ECG will be performed. Two hard copies of the ECG should be printed and 
signed by the Investigator at the site; the first copy will be kept in the subject’s medical chart and 
the second copy will be kept in the study file for retrospective collection by the Sponsor, if 
necessary. Any abnormalities should be noted and clinical relevance should be documented. An 
ECG will be recorded immediately prior to dosing and at 1 hour after abaloparatide-sMTS 
application on Day 1 (Visit 3), Day 15 (Visit 4) and Day 29 (Visit 5). Additional ECGs may be 
performed as clinically indicated. 
6.5. 
Laboratory Evaluations 
6.5.1. 
Clinical Laboratory Evaluations 
Hematology, serum chemistry, and urinalysis will be collected at time points indicated in the 
SOA in Table 1. All clinical laboratory blood and 24 hour urine samples will be sent to the local 
laboratory for analysis and testing. A list of study clinical laboratory tests is in Table 2. 
Although the Screening Period is 60 days, all enrolled subjects must have the following safety 
laboratory results reported within 30 days prior to Day 1 (Visit 3): hematology, serum chemistry 
(including calcium and phosphorus), urinalysis, PTH (intact), 25-hydroxyvitamin D, 1,25- 
dihydroxyvitamin D, and serum pregnancy. These laboratory tests must be repeated for subjects 
who were screened more than 30 days prior to Day 1 (first day of treatment). 
Subjects are required to fast for 8 hours prior to any safety laboratory assessments at Screening 
and on Days 1, 15 and 29. Subjects are allowed to continue water consumption during these 
times. 
Table 2: 
Clinical Laboratory Tests 
 
Hematology 
Serum Chemistry 
Urinalysis 
(dipstick)a 
Additional Tests 
Hemoglobin 
Sodium 
pH 
PTH (intact) b 
Hematocrit 
Potassium 
Glucose 
25-hydroxyvitamin Db 
White blood cell count 
with differential in 
absolute counts 
Chloride 
Protein 
1,25-dihydroxyvitamin Db 
Red blood cell count 
Inorganic phosphorus 
Ketones 
Urine Drug and Alcohol 
Tests 
Mean corpuscular volume 
Albumin 
Bilirubin 
24 hour urine collection 
Mean corpuscular 
hemoglobin concentration 
Total protein 
Blood 
Mean corpuscular 
hemoglobin 
Glucose 
Urobilinogen 
Estradiolb 
Platelet count 
Blood urea nitrogen 
Specific gravity 
TSHb 
Coagulation test 
Creatinine 
Nitrite 
FSHb 
Uric acid 
Leukocytes 
Serum pregnancy testb 

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Hematology 
Serum Chemistry 
Urinalysis 
(dipstick)a 
Additional Tests 
PTb 
Aspartate aminotransferase 
s-PINP 
PTTb 
Alanine aminotransferase 
cAMP 
Gamma-glutamyltranspeptidase 
Creatine phosphokinase 
Alkaline phosphatase 
Total bilirubin 
Lactate dehydrogenase 
Total Cholesterol 
Triglycerides 
Total calcium 
a) Clinic only, if required by investigator send to central lab for microscopy 
b) Only required at Screening 
Serum calcium, phosphorus and albumin will be measured predose from the standard chemistry 
panel on Day 1, Day 15 and Day 29, and from a separate blood draw at 4 hours after 
abaloparatide-sMTS application on Day 1, Day 15, and Day 29. Blood draw for cAMP will be 
done predose and 30 minutes after sMTS application at Day 1, Day 15 and Day 29. 
In the event of medically significant, unexplained, or abnormal clinical laboratory test values, the 
test(s) should be repeated and followed up until the results have returned to within the normal 
range or an adequate explanation for the abnormality is found. Clinically significant changes in 
laboratory tests that occur during the course of the study are to be reported as AEs unless 
included as part of a reported diagnosis (see Section 7). 
The clinical laboratory will clearly mark all laboratory test values that are outside the normal 
range and the Investigator will indicate the clinical relevance of these out of range values. 
6.5.2. 
Serum Markers of Bone Metabolism 
Blood samples will be taken within 1 hour predose to measure serum procollagen type I N- 
terminal propeptide (s-PINP), a marker of bone formation on Day 1 (Visit 3), Day 15 (Visit 4) 
and Day 29 / EOT (Visit 5). 
6.5.3. 
Specimen Preparation, Handling and Storage 
The procedures for the collection, handling, and shipping of clinical laboratory samples are 
specified in a separate Laboratory Manual provided to each clinical site. 
6.6. 
Imaging Procedures 
6.6.1. 
Dual Energy X-ray Absorptiometry (DXA) 
Subjects will have areal bone density measurements taken via DXA of the lumbar spine, total 
hip, femoral neck, at Screening. Lumbar spine scans must include L1 through L4. Hip scans will 
include the entire proximal femur to about 2 cm below the lesser trochanter. If a DXA is 
available that was taken in the previous 12 months and meets the above criteria, it can be used in 
place of taking a new scan. 

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6.6.2. 
Local Tolerance 
Assessment of local tolerance will consist of evaluation of signs (Section 6.6.2.1) and symptoms 
(Section 6.6.2.2) of local skin reactions. 
 
6.6.2.1. 
Investigator assessment of signs of local tolerance 
The investigator’s assessment of local tolerance will consist of evaluation of signs of local skin 
reactions, which must be performed by a physician or trained evaluator at designated study visits. 
During each clinic visit, as indicated in Table 1, the application site will be evaluated prior to the 
application of abaloparatide-sMTS, 5 minutes after application (ie, immediately upon removal of 
abaloparatide-sMTS), and 1 hour after abaloparatide-sMTS application. 
Investigators will assess each of the 12 signs of local skin reaction using a 4-point scale: 0-none, 
1-mild, 2-moderate, 3-severe. The 12 signs for local skin reactions are as follows: erythema, 
edema, vesiculation, glazed appearance, erosions, crusting, hyperpigmentation, 
hypopigmentation, scarring, atrophy, bruising, and bleeding. 
If severe local skin reactions occur, investigators may contact the Sponsor for further 
instructions. 
For any severe administration site reaction, the subject will be instructed to continue evaluations 
of the application site at 24 hour intervals until the skin irritation has stabilized or resolved. Any 
ongoing treatment-emergent local skin reactions noted on Day 29 will continue to be assessed at 
24 hour intervals until resolved or stabilized. 
 
6.6.2.2. 
Subject assessment of symptoms of local tolerance 
Study subjects will be instructed to perform a daily self-assessment of symptoms of local skin 
reaction. The application site will be evaluated prior to study drug administration, 5 minutes after 
application (ie, immediately upon removal of abaloparatide-sMTS), and 1 hour following 
abaloparatide-sMTS application on the day of clinic visits, and between visits beginning Day 1 
up until the scheduled Day 29 or EOT visit. 
The 5 symptoms of pain, itching, burning, tenderness and swelling will be assessed using a 4- 
point scale: 0-none, 1-mild, 2-moderate, 3-severe. If the subject has severe, or worsening, local 
skin reactions or any local skin reactions that have not resolved within the last 48 hours, they 
should contact the investigator for further instructions; local skin reactions may then be 
monitored by the subject every 24 hours until complete resolution. 
6.6.3. 
Residual Drug 
Residual drug evaluation from abaloparatide-sMTS which was applied and removed at the site 
will be conducted by 3M. The clinical site will collect only the abaloparatide-sMTS at Day 1, 
Day 15 and Day 29 and ship the used abaloparatide-sMTS to 3M. The abaloparatide-sMTS will 
be placed into a glass vial and labelled with subject number and visit number by clinic staff. 
Upon removal of the abaloparatide-sMTS, the skin surface will be swabbed to measure residual 
drug and the collected swabs will be shipped by the clinical site to 3M. Refer to the pharmacy 
manual for additional details. 

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6.6.4. 
Assessment of Patch Adhesion 
The patch is to be assessed by the subject for adhesion immediately prior to the removal of 
abaloparatide-sMTS at each day during the treatment period. Adhesion scores will be scored 
according to the following scoring system and recorded in the subject diary: 
0 = ≥ 90% adhered (essentially no lift off the skin) 
1 = ≥ 75% to < 90% adhered (some edges only lifting off the skin) 
2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin) 
3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off skin without 
falling off) 
4 = 0% adhered – patch detached (patch completely off the skin) 
 
6.6.5. 
Assessment of Subject Reported Outcomes 
The proposed study will be the first to generate user experience data for abaloparatide in the 
context of a clinical study. Discontinuation rates are particularly high with available osteoporosis 
therapies regardless of the mode of intake. Abaloparatide will be the first osteoporosis treatment 
delivered through a patch and could have potential to improve compliance. Previous studies have 
suggested that microneedle patches have a greater acceptability when compared with the 
traditional intramuscular hypodermic injections (Norman 2014) and may be ideal for subject 
adherence as they do not stimulate nerves that are associated with pain (Ita 2015). The additional 
endpoint assessment will determine whether the abaloparatide-sMTS is well tolerated with 
minimal impact on subject reported outcomes and improved adherence. 
Acceptability-Given the low acceptability of osteoporosis medications and subject perception of 
benefit/risk, an evaluation of acceptability will be carried out. There is currently no specific 
instrument with psychometric validation for “acceptability.” Studies including teriparatide have 
provided a single question “Is this medication acceptable to you.” (Rouphael 2017). General 
acceptability will be measured using a 5-point Likert-like scale. One being the least 
acceptable/negative experience to 5 being the most acceptable/positive experience. Acceptability 
will be assessed after abaloparatide-sMTS application on Day 1, Day 15 and Day 29. 
Question posed directly to the subject: 
• “On a scale of 1 (least acceptable/negative experience) to 5 (most acceptable/positive 
experience), how would you rate this treatment.” 
 
Subject preference of treatment attributes-While some subject reported outcomes may be 
treatment related, subjects’ preference regarding osteoporosis treatment is likely to impact their 
perception of the treatment and their behavior. As such subject preference and value for drug 
attributes will be measured after abaloparatide-sMTS application on Days 1, 15, and 29. The data 
collected will help identify which factors may affect subjects’ perspectives on risk/benefits. 
Further, which subject types may be more likely to find treatment acceptable based on value they 
place on various attributes. 
Question posed directly to the subject: 
• “Which attributes of the treatment do you find most favorable for you?” 

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• “Which attributes of the treatment do you find least favorable?” 
 
Treatment Satisfaction Questionnaire for Medication (TSQM)-Treatment satisfaction will be 
measured with the psychometrically validated treatment satisfaction questionnaire for medication 
short form (TSQM-9). TSQM has been previously used in osteoporosis studies (Palacios 2015) 
to assess satisfaction in post-menopausal women with osteoporosis (POSSIBLE US Study). 
TSQM is associated with discontinuation rates (Bharmal 2009). The 9-item questionnaire 
contains 3 domains: effectiveness, convenience, and global satisfaction. While the side effect 
domain is not included, any unpleasant experiences with a medication are likely to be captured in 
the TSQM global satisfaction items. As a result, the TSQM-9 allows for subjects to weigh the 
pros and cons of medication and the less favourable aspects of subjects’ experiences with their 
medications would be captured. The TSQM-9 domain scores range from 0 to 100 with higher 
scores representing higher satisfaction on that domain. Score can be calculated overall or for 
each domain. Only the convenience and global satisfaction domain will be assessed for the 
current study as effectiveness evaluation is not relevant given the short follow-up time. 
Measurements will be done after abaloparatide-sMTS application on Day 15 and 29. See 
appendix for the questionnaire. 
6.7. 
Discontinuation from the Study 
Subjects may voluntarily discontinue from the study for any reason at any time. 
6.7.1. 
Withdrawal of Consent 
Subjects may voluntarily withdraw consent to participate in the study for any reason at any time. 
Withdrawal of consent occurs only when a subject does not want to participate in the study 
anymore and does not want any further visits or assessments and does not want any further study 
related contact. 
If a subject withdraws consent, the Investigator must make every effort to determine the primary 
reason for this decision and record this information. Further attempts to contact the subject are 
not allowed unless safety findings require communicating or follow-up. The Sponsor may retain 
and continue to use any data collected before consent was withdrawn. 
6.7.2. 
Early Study Termination 
The study can be terminated at any time for any reason by the Sponsor. Should this be necessary, 
subjects should be seen as soon as possible and treated as a prematurely withdrawn subject. The 
Investigator may be informed of additional procedures to be followed in order to ensure that 
adequate consideration is given to the protection of the subject’s interests. 
The Investigator will be responsible for informing IRBs of the early termination of the study. 

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PLEASE SEE THE STUDY OPERATIONS MANUAL FOR DETAILED INSTRUCTIONS 
ON REPORTING OF SAEs, INCLUDING EMERGENCY CONTACT INFORMATION (eg, 
FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) 
 
7. 
ADVERSE EVENT AND SERIOUS ADVERSE EVENT 
DOCUMENTATION 
 
7.1. 
Evaluation of Safety 
Timely, accurate, and complete reporting and analysis of safety information from clinical studies 
are crucial for the protection of subjects and is mandated by Regulatory Agencies worldwide. All 
clinical studies sponsored by RADIUS will be conducted in accordance with Standard Operating 
Procedures that have been established to conform to regulatory requirements worldwide to 
ensure appropriate reporting of safety information. 
All AEs are collected from the time of signing the informed consent until 7 days after last dose 
of investigational product. At any time after 7 days from the last dose of study treatment, the 
investigator may report any SAE that he/she believes is possibly related to study treatment. 
Where possible, a diagnosis rather than a list of symptoms should be recorded. All AEs should 
be captured on the appropriate AE pages in the eCRF and in source documents. The Investigator 
will assess the relationship of all AEs to the study drug. 
7.1.1. 
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject administered a 
pharmaceutical product and that does not necessarily have a causal relationship with this 
treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) product 
AEs could include: 
• Worsening (change in nature, severity, or frequency) of conditions present at the 
onset of the study 
• Intercurrent illnesses 
• Drug interactions 
• Events related to or possibly related to concomitant medications 
• Clinically significant abnormal laboratory values (this includes significant shifts from 
Baseline within the range of normal that the Investigator considers to be clinically 
important) 
• Clinically significant abnormalities in physical examination, vital signs, and weight 
An abnormal laboratory value will not be assessed as an AE unless it requires a therapeutic 
intervention or is considered by the Investigator to be clinically significant. 
When possible, a clinical diagnosis for the study assessment should be provided rather than the 
abnormal test result alone (eg, urinary tract infection, anemia). In the absence of a diagnosis, the 

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abnormal study assessment itself should be listed as the AE (eg, bacteria in urine or decreased 
hemoglobin). 
Determination of clinical significance must be made by the Investigator. 
All skin reactions at the application site reported by the subject and investigator, expected or 
unexpected, and regardless of severity will be reported as AEs and should include reference to 
the application site. Events of ulcer, eschars, and non-healing wounds at the application site will 
be evaluated as an adverse event of special interest (Skin AESI). Skin AEs that occur at other 
locations of the body should be reported as AEs as appropriate but are not to be recorded/entered 
using phrases such as ‘at the application site’, ‘involving the application site’, etc., to ensure the 
phrase ‘application site’ is used exclusively for the sites of study drug administration. 
7.1.2. 
Serious Adverse Event (SAE) 
An SAE is any AE that results in any of the following: 
• Death 
• Life-threatening: The term “life-threatening” in the definition of “serious” refers to an 
event/reaction in which the subject was at risk of death at the time of the 
event/reaction; it does not refer to an event/reaction which hypothetically might have 
caused death if it were more severe. 
• Hospitalization or prolongation of existing hospitalization. 
• Persistent or significant disability/incapacity (ie, substantial disruption of the ability 
to conduct normal life function). 
• Congenital anomaly/birth defect. 
• Important medical events that may not result in death, are life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
subject hospitalization, or the development of drug dependency or drug abuse. 
All AEs of osteosarcoma will be reported as SAEs. 
All treatment related AEs/SAEs noted on the follow-up visit must be followed until resolution 
(subject has returned to baseline status of health) or until stabilization (the Investigator does not 
expect any further improvement or worsening of the reported event), or until the subject is lost to 
follow-up. 
7.1.3. 
Recording an Adverse Event 
All AEs/SAEs spontaneously reported by the subject and/or in response to an open question from 
study personnel or revealed by observation, physical examination, or other diagnostic procedures 
must be recorded in the source document and entered into the electronic database. 
Planned hospital admissions or surgical procedures for an illness or disease that existed before 
the subject was enrolled in the study are not to be considered AEs unless they occur at a time 

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other than the planned date or the pre-existing illness or disease worsens after enrollment into the 
study. 
For both serious and non-serious adverse events, the Investigator must determine the intensity of 
the event and the relationship of the event to study drug administration. Intensity for each AE 
will be defined according to the following criteria: 
 
Intensity 
Definition 
 
Mild 
Awareness of sign or symptom, but easily 
tolerated. 
 
Moderate 
Discomfort enough to cause interference 
with normal daily activities. 
 
Severe 
Inability to perform normal daily activities. 
 
If the intensity of an adverse event changes within a day, the maximum intensity should be 
recorded. If the intensity changes over a longer period of time, the changes should be recorded as 
separate events (having separate onset and stop dates for each intensity). 
Relationship to study drug or device, defined as study drug administration will be determined by 
the Investigator according to the following criteria: 
 
Relationship 
Definition 
 
None 
No relationship between the event and the 
administration of study drug. The event is 
related to other etiologies, such as 
concomitant medications or subject’s 
clinical state. 
 
Unlikely 
The current state of knowledge indicates that 
a relationship to study drug administration is 
unlikely or the temporal relationship is such 
that study drug administration would not 
have had any reasonable association with the 
observed event. 
 
Possible 
A reaction that follows a plausible temporal 
sequence from administration of the study 
drug and follows a known response pattern 
to the suspected study drug. The reaction 
might have been produced by the subject’s 
clinical state or other modes of therapy 
administered to the subject. 

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Relationship 
Definition 
 
Probable 
A reaction that follows a plausible temporal 
sequence from administration of the study 
drug and follows a known response pattern 
to the suspected study drug. The reaction 
cannot be reasonably explained by the 
known characteristics of the subject’s 
clinical state or other modes of therapy 
administered to the subject. 
 
For the purpose of safety analyses, all AEs that are classified with a relationship to study 
medication administration of possible or probable will be considered treatment-related events. 
The AE will be determined to be device-related if it is identified to have had a probable or 
possible causal relationship to the investigational device. 
 
7.1.3.1. 
Serious and Unanticipated Adverse Device Effects for Abaloparatide-sMTS 
An adverse device effect is defined as any adverse event that may or may not be related to the 
investigational abaloparatide-sMTS device and should be reported as an AE (Section 7.1.1), and 
includes AEs resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, operation, malfunction, use error or from intentional misuse of the 
investigational medical device. 
An unanticipated adverse device effect (UADE) is defined as any SAE on health or safety or any 
life-threatening problem or death caused by, or associated with, the abaloparatide-sMTS device, 
or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
The Investigator and the Sponsor will immediately conduct an evaluation of any UADE 
occurring with abaloparatide-sMTS. The results of the evaluation will be reported to the IRB 
within 10 days of the Investigator and/or the Sponsor becoming aware of the event. If it is 
determined by the Investigator and the Sponsor to present an unreasonable risk to study 
participants, all investigations or parts of the investigation presenting that risk will be terminated 
as soon as possible. Termination will occur not later than 5 working days after the Investigator 
and the Sponsor makes this determination, and not later than 15 working days after first 
receiving notice of the event. The Investigator and the Sponsor will not resume an investigation 
terminated under these conditions without an additional IRB approval. 
7.1.4. 
Serious Adverse Event Reporting 
Any SAEs that occur during the study from the time the subject signs the ICF until 7 days after 
the last dose of study medication must be reported within 24 hours of first awareness of the event 
by completing and faxing the SAE Form and entering data in the clinical trial eCRF. In addition, 
all SAEs including all deaths which occur up to and including 7 days after administration of the 
last dose of study drug, must be reported to the Medical Monitor within 1 working day. SAE 
forms will be provided to the clinical study site. The reference safety information for this study is 
included in the IB, which will be provided under separate cover to all investigators. 

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Any SAEs that occur at any time after completion of the study, which the Investigator considers 
to be related to study drug, must be reported to the Sponsor or its designee. 
The Investigator must submit the SAE to the IRB in accordance with 21 CFR parts 56 and 312 as 
well as with applicable local regulations. Documentation of these submissions must be retained 
in the site study file. 
7.1.5. 
Device Reporting 
Abaloparatide-sMTS is a drug-device combination product. In order to fulfil regulatory reporting 
obligations worldwide the investigator is responsible for the detection and documentation of 
events meeting the definition of UADEs that occur with abaloparatide-sMTS (Section 7.1.3.1). 
Any UADEs that occur during the study with abaloparatide-sMTS from the time the participant 
signs the ICF until 30 days after the last dose of study medication must be reported within 
24 hours of first awareness that the event meets the definition of a reportable incident by entering 
data in the clinical trial eCRF. Treatment-related UADEs will be followed until resolution or 
stabilization, the condition is otherwise explained, or until the subject is lost to follow-up. 
The investigator will comply with the applicable local regulatory requirements relating to the 
reporting to the IRB. 
7.1.6. 
Follow-up of Adverse Events 
All treatment-related AEs will be followed with appropriate medical management until resolved 
or stabilized, or the subject is lost to follow-up. UADEs will be followed until their medical 
outcome is determined, with periodic written reports about the status provided to the study 
Sponsor. 
 
7.1.7. 
Overdose 
An overdose of abaloparatide-sMTS is the intentional or unintentional application of a dose of 
abaloparatide that is greater than intended, such as using multiple patches on the same day. 
Overdoses must be reported to the Sponsor whether or not they result in an AE/SAE. In the event 
of an overdose the Investigator should contact the Medical Monitor immediately and closely 
monitor the subject for AEs and laboratory abnormalities. No specific treatment is 
recommended; the investigator will use clinical judgment to treat any overdose. 
7.1.8. 
Regulatory Agency, Institutional Review Board, and Site Reporting 
The sponsor and/or the clinical contract research organization are responsible for notifying the 
relevant regulatory authorities/ IRBs of related, unexpected SAEs. 
The investigator is responsible for notifying the sponsor, CRO, and local IRB, or the relevant 
local regulatory authority of all SAEs that occur at his or her site as required. 
7.2. 
Study Completion and Post-Study Treatment 
The Investigator must provide follow-up medical care for all subjects who are prematurely 
withdrawn from the study due to a treatment-related adverse event or must refer them for 
appropriate ongoing care. 

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7.3. 
Lost to Follow-up 
For subjects whose status is unclear because they fail to appear for study visits without stating an 
intention to discontinue or withdraw, the Investigator should show “due diligence” by 
documenting in the source documents steps taken to contact the subject, eg, dates of telephone 
calls, registered letters, etc. A subject should not be formally considered lost to follow-up until 
his scheduled Visit 6/follow-up visit would have occurred. 

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8. STATISTICAL CONSIDERATIONS 
8.1. 
Statistical and Analytical Plans 
A comprehensive Statistical Analysis Plan (SAP) and a Pharmacometric Analysis Plan will be 
completed and approved prior to database lock. 
 
8.2. 
Statistical Hypotheses 
The primary objective of this study is to evaluate the ability of subjects to self-administer 300 µg 
abaloparatide sMTS over a period of 29 days based on pharmacokinetic (PK) and 
pharmacodynamic (PD) markers. 
No formal statistical tests will be conducted for any of the study endpoints. 
 
8.3. 
Analysis Datasets 
8.3.1. 
Population for Analysis 
The primary population for all safety analyses will be the Safety Population, which will be 
defined as all subjects who received at least 1 dose of study medication. 
The primary population for PK analyses will be the Pharmacokinetic (PK) Analysis Population, 
which will include all subjects in the Safety Population who have sufficient evaluable plasma 
concentrations to reliably estimate 1 or more PK parameters. 
 
8.4. 
Description of Statistical Methods 
8.4.1. 
General Approach 
Baseline is defined as the last value obtained prior to the first dose of study medication. 
For categorical data, summary tabulations of the number and percentage of subjects within each 
category of the parameter will be presented. For continuous data, the number of subjects, mean, 
median, standard deviation (SD), minimum, interquartile range (Q1 and Q3), and maximum will 
be presented, unless otherwise specified. 
 
8.4.2. 
Analysis of the Primary Endpoint 
The primary population for the analysis of the PK parameters will be the PK Analysis 
Population. 
Individual plasma concentrations of abaloparatide will be listed and summarized by visit and 
sampling time. Concentration data will be summarized at each nominal time point with the 
following descriptive statistics: number of subjects, mean, SD, coefficient of variation (CV%), 
median, minimum, and maximum. Individual plasma concentrations will be plotted vs nominal 
sampling time on linear-linear and log-linear scales by visit. Spaghetti plots of abaloparatide 
plasma concentrations will also be prepared. 

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The following PK parameters will be derived: 
 
Parameters 
Description 
AUC0-t 
Area under the plasma concentration-time curve from time zero to the 
time of the last quantifiable concentration 
AUC0-inf 
Area under the plasma concentration-time curve from time zero to 
infinity 
Cmax 
Maximum observed plasma concentration 
tmax 
Time of maximum observed plasma concentration 
t1/2 
Apparent terminal phase half-life 
λz 
Elimination rate constant 
 
All plasma PK parameter calculations will be performed using actual time (or nominal time, 
when actual time is not available) calculated relative to the time of study drug administration. PK 
parameters will be determined using non-compartmental methods based on individual plasma 
concentration-time data for abaloparatide. Individual plasma PK parameters will be listed and 
summarized by visit. PK parameters will be summarized with the following descriptive statistics: 
number of subjects, mean, SD, CV%, median, minimum, maximum, geometric mean (Geo 
Mean), and coefficient of variation of the geometric mean (Geo Mean CV%). 
Comparisons between the abaloparatide PK parameter values on Day 15 and on Day 29 vs Day 1 
(based on natural log (ln)-transformed AUC0-inf, AUC0-t, and Cmax) will be conducted. Point 
estimates and 90% CIs for the difference in PK parameter values between visits will be obtained. 
Further details will be described in the Pharmacometric Analysis Plan. 
 
8.4.3. 
Analysis of Secondary Endpoints 
The primary population for the analysis of the secondary endpoints will be the Safety Population, 
unless otherwise specified. 
Pharmacodynamic endpoints 
The change from baseline, percentage change from baseline and ratio of post-baseline value to 
baseline value in s-PINP will be summarized descriptively by visit, together with the 90% CI. 
The actual values change from baseline values, and the percentage change from baseline values 
for serum calcium (albumin-corrected), serum phosphorus, and cAMP will be summarized using 
descriptive statistics by visit and timepoint. 
Local Tolerance 
Local tolerance is defined as the assessment of signs (investigator) or symptoms (subject) of 
local skin reactions. For the investigator assessment of signs of local skin reactions, the number 
(%) of subjects in each response category of the 4-point scale will be provided per visit and 
timepoint. The maximum severity of reaction scores will be similarly summarized for each 
response category by visit. 

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For the subject assessment of symptoms of local skin reactions, the mean of the local tolerance 
scores across the entire treatment period and at the Follow-Up visit will be calculated for each 
response category of the 4-point scale per subject by timepoint. The mean local tolerance score 
will be summarized using descriptive statistics by response category and timepoint. Frequency 
counts (and percentages) for the maximum severity of reaction scores for each response category 
by timepoint will be presented. 
In addition, the subject assessment of symptoms of local skin reactions collected at the clinic 
visits will be separately summarized, with the number (%) of subjects in each response category 
of the 4-point scale provided per visit and timepoint. The maximum severity of reaction scores 
collected at the clinical visits will be similarly summarized for each response category by visit. 
Subject Reported Outcomes: 
• TSQM9- Global Satisfaction and Convenience Domains 
− Mean TSQM-9 score (±standard error [SE]) for each domain will be tabulated for 
Day 15 and Day 29 for the subjects who completed the study 
− Association between improvement in convenience and satisfaction score 
(TSQM9) and adherence (definition of adherence will be provided in the SAP) 
• 5-point Likert-like scale of acceptability will be tabulated and summarized 
− Mean score (±SE) will be tabulated for Day 1, 15, and 29 
− Association between improvement in acceptability and adherence will be assessed 
• Subject Preference for treatment attributes will be summarized 
− Pending data availability, association between subject preference for treatment 
attributes and subsequent acceptability and satisfaction will be evaluated 
separately for: outcome (effectiveness/safety) and other attributes (duration, 
frequency of use, mode of intake). 
Patch Adhesion Score: 
Frequency counts (and percentages) for the patch adhesion score collected at each clinic visit 
will be summarized by visit, along with the best adhesion score (ie, lowest patch adhesion score 
per subject) and the worst adhesion score (ie, highest patch adhesion score per subject). 
The mean of the patch adhesion scores collected from Day 1 to Day 29 will be calculated for 
each subject. The mean patch adhesion score will be summarized using descriptive statistics for 
the entire treatment period. The mean of each subject’s best adhesion score and worst adhesion 
score will also be summarized. 
Abaloparatide-sMTS Released Dose 
Descriptive statistics will be provided to summarize the abaloparatide-sMTS released dose, the 
percentage of released dose to nominal dose, the percentage of release dose to initial 
abaloparatide-sMTS content, the residual drug amount from abaloparatide-sMTS, the residual 
drug amount from abaloparatide-sMTS, and the residual drug amount from abaloparatide-sMTS 
and swab, by visit. 

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Details of analyses will be described in the SAP. 
 
8.4.4. 
Safety Analyses 
All safety analyses will be conducted using the Safety Population and will be descriptive in 
nature. 
Study drug exposure and study drug compliance will be calculated. The duration of study drug 
exposure, total dose received, and percent compliance will be summarized. 
All AEs will be coded using the current version of MedDRA available at the time of study start. 
The number and percent of subjects who experienced treatment-emergent AEs (TEAEs) will be 
summarized by MedDRA system organ class (SOC) and preferred term. Summaries will also be 
provided for severe TEAEs, severe related TEAEs, serious TEAEs, serious related TEAEs, 
TEAEs leading to study withdrawal, drug-related TEAEs (with probable or possible relationship 
to study drug), and TEAEs by maximum severity (mild, moderate, severe). A summary will also 
be provided most common (≥ 5%) TEAEs. 
Summaries will be provided for Skin and Hypersensitivity AESIs for TEAEs by SOC and 
preferred term, severe TEAEs, severe related TEAEs, serious TEAEs, serious related TEAEs, 
TEAEs leading to study withdrawal, drug-related TEAEs (with probable or possible relationship 
to study drug), and TEAEs by maximum severity (mild, moderate, severe). A summary will also 
be provided most common (≥ 5%) TEAEs for each AESI. 
All AEs collected prior to the first dose of study drug will be summarized separately. 
A listing of subjects who experience a UADE will be provided. 
Descriptive statistics for laboratory data (including albumin corrected serum calcium, 
phosphorus and cAMP), vital signs (including orthostatic BP), and ECGs will be provided by 
visit and time point (when applicable). For laboratory data, vital signs and ECGs, absolute results 
and changes from baseline will be presented. In addition, laboratory test results will be classified 
as above normal limit, within normal limit, or below normal limit. Laboratory shift frequencies 
will be tabulated between the Screening visit and relevant post-baseline visit(s). 
Concomitant medications will be coded using the World Health Organization (WHO) Drug 
Dictionary and summarized by number and percentage of subject using each class and preferred 
drug term. 
 
8.4.5. 
Adherence and Retention Analyses 
The number and percentage of subject who withdraw from the study, with primary reason, will 
be summarized. 
 
8.4.6. 
Baseline Descriptive Statistics 
Medical history, physical examination, demographics and baseline characteristics will be 
summarized and presented. Medical history will be presented by MedDRA SOC and preferred 
term, summarizing the proportion of subject who have a condition noted. Results from the 
baseline physical examination will be summarized by body system as recorded in the eCRF. 

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8.4.7. 
Interim Analyses 
There are no interim analyses planned for this study. 
 
8.4.8. 
Additional Subgroup Analyses 
Subgroup analysis may be performed and will be described in the SAP. 
 
8.4.9. 
Multiple Comparison/Multiplicity 
No formal statistical tests will be performed, and hence no adjustments for multiple comparisons 
will be made. 
 
8.4.10. 
Tabulation of Individual Response Data 
Individual efficacy and safety data will be tabulated as appropriate. 
 
8.4.11. 
Exploratory Analyses 
Additional exploratory analyses may be presented as either planned (and described in the SAP) 
or post-hoc to complement the overall understanding of study results. 
 
8.5. 
Sample Size Calculation 
This is a hypothesis generating study and the sample size is based on previous clinical trial 
experience without a formal power calculation. 
 
 
8.6. 
Measures to Minimize Bias 
Not applicable. 
 
8.7. 
Enrollment/Randomization/Masking Procedures 
Treatment will not be blinded. 

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9. ADMINISTRATIVE REQUIREMENTS 
9.1. 
Ethical Considerations 
This clinical study will be conducted in accordance with the current version of International 
Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical 
Practice (GCP), with applicable local laws and regulations, and with the ethical principles laid 
down in the Declaration of Helsinki. 
The Investigator will ensure that this study is conducted in full conformity with Regulations for 
the Protection of Human Subjects of Research codified in 21 CFR Part 50, 21 CFR Part 54, 21 
CFR Part 56, 21CFR Part 312, 21 CFR Part 314 and ICH GCP E6. 
The IRB will review all appropriate study documentation to safeguard the rights, safety, and 
well-being of the subjects. The study will only be conducted at sites where IRB approval has 
been obtained. The protocol, IB, ICF, advertisements (if applicable), written information given to 
the subjects, safety updates, annual progress reports, and any revisions to these documents will 
be provided to the IRB by the Investigator or RADIUS or designee, as allowable by local 
applicable laws and regulations. 
 
9.2. 
Subject Information and Informed Consent 
The Investigator is responsible for obtaining written, informed consent from each subject 
interested in participating in this study before conducting any study-related procedures. 
Written informed consent should be obtained after adequate, thorough, and clear explanation of 
the study objectives, procedures, as well as the potential hazards of the study. The method of 
obtaining and documenting the informed consent and the contents of the consent will comply 
with ICH GCP and all applicable laws and regulations and will be subject to approval by 
RADIUS or its designee. 
9.3. 
Investigator Compliance 
No modifications to the protocol should be made except where the modification is necessary to 
eliminate an apparent immediate hazard to human subjects. RADIUS will submit all protocol 
modifications as amendments to the required regulatory authorities. 
When circumstances require an immediate departure from procedures set forth in the protocol, 
the Investigator will contact RADIUS to discuss the planned course of action. If possible, contact 
should be made before the implementation of any changes. Any departures from protocol must 
be fully documented in the source documentation. 
9.4. 
Access to Records 
The Investigator must make the office and/or hospital records of subjects enrolled in this study 
available for review by site monitors at the time of each monitoring visit, audit by RADIUS QA 
and inspection by the regulatory agencies. The records must also be available for inspection, 
verification, and copying, as required by applicable laws and regulations, by officials of the 
regulatory health authorities (Food and Drug Administration and others). The Investigator must 

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comply with applicable privacy and security laws for use and disclosure of information related to 
the research set forth in this protocol. 
 
9.5. 
Subject and Data Confidentiality 
To maintain subject confidentiality, all eCRFs, study reports and communications relating to the 
study will identify subject by unique subject ID numbers assigned to each subject. As required 
by federal regulations, the Investigator will allow RADIUS and/or its representatives access to 
all pertinent medical records to allow for the verification of data gathered in the eCRFs/SAE 
Forms/source data documents and the review of the data collection process. The Food and Drug 
Administration (or other regulatory authority) may also request access to all study records, 
including source documentation, for inspection. 
As applicable, in accordance with the Health Insurance Portability and Accountability Act 
(HIPAA) and associated privacy regulations, a subject authorization to use personally 
identifiable health information may be required from each subject before research activities 
begin. 
Subject confidentiality is strictly held in trust by the participating Investigators, their staff, and 
RADIUS and their representatives. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to study subjects. 
Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of RADIUS. 
9.6. 
Research Use of Stored Human Samples, Specimens, or Data 
With the subject’s approval, and as approved by the site’s IRB, biological samples may be stored 
at a centralized facility determined by RADIUS. These samples could be used for retrospective 
biomarker research or analysis of clinical response to therapy and to improve current and future 
treatment outcomes. The storage facility will maintain the masking of the identity of the subject. 
During the conduct of the study, any individual subject can choose to withdraw consent to have 
biological specimens stored for future research. When the study is completed, access to study 
data and/or samples will be provided through RADIUS. 
 
9.7. 
Data Quality Assurance 
RADIUS or its designated representative will conduct a study site visit to verify the 
qualifications of each Investigator, inspect clinical study site facilities as needed, and inform the 
Investigator of responsibilities and procedures for ensuring adequate and correct study 
documentation. 
The Investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the study for each study subject. 
Study data for each enrolled subject will be entered into an eCRF by site personnel using a 
secure, validated web-based electronic data capture (EDC) application. RADIUS will have read- 
only access to all data upon entry in the EDC application. Study assessment data generated by 
contracted 3rd party vendors will be obtained via external data transfers (outside the EDC 
application) and reconciled against confirmatory data contained in the EDC system by RADIUS’ 

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designee. External data will be incorporated into Study Data Tabulation Model (SDTM) datasets 
by RADIUS’ designee for RADIUS’ use. 
Instances of missing, discrepant, or uninterpretable data will be queried with the Investigator for 
resolution. Any changes to study eCRF data will be made in the eCRF and documented in an 
audit trail, which will be maintained within the clinical database. Changes to external data will 
be handled exclusively by the 3rd party vendor responsible for the data. 
To ensure compliance with GCP and all applicable regulatory requirements, a quality assurance 
audit may be conducted. Regulatory agencies may also conduct a regulatory inspection of this 
study. Such audits/inspections can occur at any time during or after completion of the study. If an 
audit or inspection occurs, the Investigator and institution agree to allow the auditor/inspector 
direct access to all relevant documents and to allocate his/her time and the time of his/her staff to 
the auditor/inspector to discuss findings and any relevant issues. In the case of an audit or 
inspection, the Investigator or a delegate will alert RADIUS, as soon as he/she becomes aware of 
the audit or inspection. 
The Investigator and study staff are responsible for maintaining a comprehensive and accurate 
filing system of all study-related documentation that will be suitable for inspection at any time 
by RADIUS, its designees, and/or regulatory agencies. In signing this protocol, the Investigator 
understands and agrees to give access to the necessary documentation and files. 
 
9.8. 
Monitoring 
RADIUS is responsible for ensuring the proper conduct of the study with regard to protocol 
adherence and validity of data recorded in the clinical database. The study will be monitored by 
RADIUS or its designee. Monitoring will be done by personal visits from a representative of 
RADIUS, or designee (site monitor), who will review the eCRFs, SAE Forms and source 
documents. The site monitor will ensure that the investigation is conducted according to the 
protocol design and regulatory requirements. 
 
9.9. 
Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical study staff at the site under the supervision of 
the Investigator. The Investigator is responsible for ensuring the accuracy, completeness, 
legibility, attributability, and timeliness of the data reported. 
RADIUS or its designee will provide the study sites with secure access to and training on the 
EDC application sufficient to permit site personnel to enter and correct information in the eCRFs 
on the subject for which they are responsible. 
An eCRF will be completed for each subject who receives at least 1 dose of study drug. Nominal 
data, limited to demographics and the reason for screen failure, will be collected for all subjects 
who sign an ICF but are not randomized, although additional data will be collected if a screen 
failure experiences an adverse event during while being screened. It is the Investigator's 
responsibility to ensure the accuracy, completeness, clarity, attributability, and timeliness of the 
data reported in the subject’s eCRF. Source documentation supporting the eCRF data should 
indicate the subject’s participation in the study and should document the dates and details of 
study procedures, AEs, other observations, and subject status. 

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The Investigator, or designated representative, should complete the eCRF in a timely manner 
after information is collected. 
The audit trail entry will show the user's identification information, the date and time of log in, 
the date and time of data entry and/or any change or correction to previously entered data, as 
well as the reason for any data change. The Investigator must provide formal approval of all the 
information in the eCRFs, including any changes made to the eCRFs, to endorse the final 
submitted data for the subjects for whom the Investigator is responsible. 
RADIUS will retain the eCRF data, queries and corresponding audit trail. A copy of the final 
archival eCRF in the form of a compact disc or other electronic media will be provided to the site 
for placement in the Investigator's study file. 
 
9.10. 
Study Records Retention 
The Investigator will maintain study documents for a minimum of 2 years after the last approval 
of a marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents will be 
retained for a longer period, however, if required by local regulations. If the Investigator 
withdraws from the responsibility of keeping the study records, custody must be transferred to a 
person willing to accept the responsibility and RADIUS must be notified. No records will be 
destroyed without the written consent of RADIUS. 
 
9.11. 
Publication and Data Sharing Policy 
Publication of complete data from the study is planned. It is anticipated that the results of this 
study will be presented at scientific meetings and/or published in a peer reviewed scientific or 
medical journal. A Publications Committee composed of Investigators participating in the study 
and representatives from RADIUS as appropriate will be formed to oversee the publication of the 
study results, which will reflect the experience of all participating study centers. 
Subsequently, individual Investigators may publish results from the study in compliance with 
their agreement with RADIUS. 

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10. 
LITERATURE REFERENCES 
 
Barrett-Connor E, Wade SW, Do TP, et al. Osteoporos Int (2012) 23: 733. 
Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an 
abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on 
antihypertensive medications. Health Qual Life Outcomes. 2009;7: 36. 
Black DM, Arden NK, Palermo L, Pearson J, Cummings SR. Prevalent vertebral deformities 
predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic 
Fractures Research Group. J Bone Miner Res. 1999; 14(5): 821-828. 
Bilezikian JP. Anabolic therapy for osteoporosis. Women’s Health (Lond). 2007;3:243-253. 
Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid 
hormone on bone. Endocr Rev. 1993;14:690–709. 
Ebeling PR. Osteoporosis in men. New Engl J Med. 2008;358:1474-1482. 
Ensrud KE, Blackwell TL, Cawthon PM, et al. Degree of Trauma Differs for Major Osteoporotic 
Fracture Events in Older Men Versus Older Women. J Bone Miner Res. 2016; 31(1): 204-207. 
Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding selectivity of abaloparatide for 
PTH-type-1-receptor conformations and effects on downstream signaling. Endocrinology. 
2016;157:141-49. 
International Osteoporosis Foundation. Osteoporosis in men. 2014; accessed via 
http://www.iofbonehealth.org/WOD/2014/thematic-report/WOD14-Report.pdf 
Ita, K. Transdermal Delivery of Drugs with Microneedles-Potential and Challenges. 
Pharmaceutics. 2015; 7(3): 90-105. 
Kanis JA, ￼ O, De Laet C, et al. A meta-analysis of previous fracture and subsequent fracture 
risk. Bone. 2004;35(2): 375-382. 
Khosla S, Amin S, Orwoll E. Osteoporosis in men. Endocrine Rev. 2008;29:441-464. 
Li G, Thabane L, Papaioannou A, Adachi JD. Comparison between frailty index of deficit 
accumulation and fracture risk assessment tool (FRAX) in prediction of risk of fractures. Bone. 
2015; 77: 107-114. 
Li G, Ioannidis G, Pickard L, et al. Frailty index of deficit accumulation and falls: data from the 
Global Longitudinal Study of Osteoporosis in Women (GLOW) Hamilton cohort. BMC 
Musculoskelet Disord. 2014; 15: 185. 
Lindsay R, Silverman SL, Cooper C, MD; et al. Risk of New Vertebral Fracture in the Year 
Following a Fracture. JAMA. 2001;285(3):320-323. doi:10.1001/jama.285.3.320 
Litwic A, Lekarz, Warwick D, Denniston E. Distal radius fracture: Cinderella of the osteoporotic 
fractures. Orthop Muscul Syst. 2014; 3:162-8. 
Makino M, Takagi H, Sugiyama H, Kobayashi T, Kasahara Y. Effects of abaloparatide on the 
expression of bone resorption and formation-related factors in osteoblastic cells; a comparison 

Radius Health, Inc. 
Confidential 
Study BA058-05-022, Amendment 1, 18 March 2019 
Page 62 of 62 
 
 
 
with teriparatide. Annual Meeting of the American Society for Bone and Mineral Research 2015; 
MO0121. 
Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: Their biological 
importance and functional properties. Am J Physiol. 1999; 277:F665-F675 
Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, 
Hu M, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C. Effect of abaloparatide vs placebo 
on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical 
trial. J Am Med Assoc. 2016;316:722-733. 
Newcombe RG. Interval estimation for the difference between independent proportions: 
Comparison of eleven methods. Stat Med. 1998; 17:873-890. 
Norman JJ, Arya JM, McClain MA, Frew PM, Meltzer MI, Prausnitz MR. (2014). Microneedle 
patches: usability and acceptability for self-vaccination against influenza. Vaccine. 2014;32(16): 
1856-1862. 
Palacios S, Agodoa I, Bonnick S, et al. Treatment satisfaction in postmenopausal women 
suboptimally adherent to bisphosphonates who transitioned to denosumab compared with 
risedronate or ibandronate. J Clin Endocrinol Metab. 2015; 100(3): E487-492. 
Rizzoli R. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001;26:79-94. 
Robinson, CM, Royds M, Abraham A, McQueen MM, Court-Brown CM, Christie J. Refractures 
in patients at least forty-five years old. a prospective analysis of twenty-two thousand and sixty 
patients. J Bone Joint Surg Am. 2002; 84-a(9): 1528-1533. 
Rouphael NG, Paine M, Mosley r, et al. The safety, immunogenicity, and acceptability of 
inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, 
partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017; 390(10095): 649-658. 
Rosen CJ. Clinical practice. Postmenopausal osteoporosis. N Engl J Med. 2005;353:595-603. 
Suzuki N, Ogikubo O, Hansson T. The course of the acute vertebral body fragility fracture: its 
effect on pain, disability and quality of life during 12 months. Eur Spine J. 2008; 17(10): 1380- 
1390. 
World Health Organization (WHO). Assessment of osteoporosis at the primary health care level. 
Summary of a WHO Scientific Group 2007 [16 Feb 2017]. Available from: 
www.who.int/chp/topics/rhuematicrheumatic/en/index.html 

 
19-Mar-2019 19:52:39 GMT+0000 
Approval 
20-Mar-2019 11:39:53 GMT+0000 
Approval 
20-Mar-2019 12:57:03 GMT+0000 
Approval 
 
 
Signature Page for RAD-CLIN-001055 v2.0 
 
 
 
 
 
Signature Page for RAD-CLIN-001055 v2.0