Clinical trial NCT04366726: Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
Official title: A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Keywords: postmenopausal osteoporosis
transdermal delivery
microstructure patch
abaloparatide
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

Detailed description: This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal for at least 2 years
* 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)
* Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m\^2)
* Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
* Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)

Exclusion Criteria:

* History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
* History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
* History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
* History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
* Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
* Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants 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
* Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer

Primary outcomes:
measure: Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
timeFrame: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
measure: Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29
timeFrame: 0 (predose) and 4 hours postdose on Day 29
Secondary outcomes:
measure: Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29
timeFrame: Baseline, Day 29
measure: Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
timeFrame: Baseline, 0 (predose) and 4 hours postdose on Day 29
measure: Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
timeFrame: Baseline, 0 (predose) and 4 hours postdose on Day 29
measure: Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
timeFrame: Baseline, 0 (predose) and 30-minutes postdose on Day 29
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc
state: Kansas
Study officials:
affiliation: Radius Health, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Miller PD, Troy S, Weiss RJ, Annett M, Schense J, Williams SA, Mitlak B. Phase 1b Evaluation of Abaloparatide Solid Microstructured Transdermal System (Abaloparatide-sMTS) in Postmenopausal Women with Low Bone Mineral Density. Clin Drug Investig. 2021 Mar;41(3):277-285. doi: 10.1007/s40261-021-01008-7. Epub 2021 Feb 27.