Osteoporosis Treatment Response Assessed by Micromechanical Modeling of MRI Data
Phase: NA
Conditions: Bone Alteration
Sponsor: University of Pennsylvania

 
 
 
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STUDY PROTOCOL 
 
 
Title: Micromechanical Modeling Using Low Magnitude Mechanical Stimulation (LMMS) 
 
NCT: 01921517 
 
Date uploaded to clinicaltrials.gov: 09/19/2019 
 
Date most recently uploaded to human subjects protection review board: 10/24/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Introduction 
This double-blinded, translational, human subject study will test the hypothesis that postmenopausal women, 
subjected to a daily 10-minute treatment of LMMS (low magnitude mechanical stimulation) for one year, will 
show an improvement in trabecular and cortical stiffness and failure strength at the tibia, along with a reduction 
in vertebral marrow adiposity relative to their placebo-treated peers. The intervention and measurement 
protocols pose minimal risk to participants. 
 
Abstract 
We propose to evaluate the hypothesis that LMMS applied to postmenopausal women ages 45-65 improves 
the bone’s mechanical integrity while lowering marrow adiposity. Specific Aims are: 1) We will optimize an 
integrated imaging protocol for high-resolution structural MR imaging of the distal tibia and spectroscopic 
imaging-based quantification of bone marrow composition in the lumbar vertebrae; 2) We will further develop 
and validate micro-finite-element (FE) analysis for quantitative assessment of trabecular and cortical bone 
stiffness and failure load from high-resolution MR images of the distal tibia, and 3) We will apply the 
methodology of Aims 1 and 2 in a double-blinded, randomized, placebo-controlled study to a cohort of 64 
healthy postmenopausal women in the age range of 45-65 years, studied at baseline and 12 months after 
having been subjected to 10 minutes daily of either 30 Hz/0.3g stimulation or placebo treatment, monitored 
rigorously via electronic feedback. 
 
Overall objectives 
We hypothesize that relative to placebo, LMMS treatment will result in: 1) increased trabecular and cortical 
stiffness and failure strength assessed at the distal tibia by MR image-based FE modeling; 2) increased BMD 
at the two peripheral sites measured by pQCT, and DXA of the spine and hip, and 3) reduced vertebral marrow 
adiposity, which will be reciprocally related to measures of BMD and strength. 
 
Primary outcome variable(s) 
Increased trabecular and cortical stiffness and failure strength, assessed at the distal tibia by MR image-based 
FE modeling. 
 
Secondary outcome variable(s) 
Increased BMD at the two peripheral sites measured by pQCT and DXA of the spine and hip. 
 
Background 
Weight bearing exercise has an osteogenic effect by reducing bone resorption and enhancing bone formation. 
During the past several years a number of articles have appeared demonstrating that low magnitude 
mechanical stimulation (LMMS) is osteogenic in animals and also in humans. The mechanobiology underlying 
these phenomena is beginning to emerge in terms of expression of genes stimulated by the action of the 
vibrations to which osteocytes are subjected. If successful, LMMS treatment, a non-pharmacologic 
intervention, could prevent bone loss and potentially stimulate bone formation resulting in increased bone 
strength and reduced fracture susceptibility in subjects at risk of developing osteoporosis. The proposed 
project focuses directly on measures of strength by evaluating the therapeutic response in terms of magnetic 
resonance (MR) image-based micro finite-element (FE) assessment of bone stiffness and failure strength, 
along with quantifying treatment-induced changes in marrow adiposity, as part of a single, integrated 
examination, conducted at baseline and 12 months of treatment in a double-blinded, randomized, placebo-
controlled study of postmenopausal women. Special consideration will be given to compliance, which will be 
enhanced by an electronic feedback system. 
 
Study phase    
Phase II 
 
Study design 
Double blinded, randomized, placebo-controlled. 
 

 
 
 
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Study duration 
Estimated length of time for enrollment:  
2 years 
Length of time of subject participation:  
1 year 
 
Resources necessary for human research protection 
All research staff involved with this study are experienced performing MRI studies of this type and all have 
completed the required training in human subjects research protection. The DXA and pQCT studies will take 
place in The Nutrition and Growth Lab at Children’s Hospital of Philadelphia. The Nutrition and Growth Lab is 
used for many of the studies involving DXA and pQCT at the University of Pennsylvania. The MRI research 
facility at the University of Pennsylvania has dedicated scanners devoted to various research projects. 
Subjects will be recruited from a database of previous study participants as well as with outreach efforts to the 
University and general community via advertisements, letters and notices.  
 
Target population 
Post-menopausal female subjects ages 45-65 years who have a history of amenorrhea for a minimum of 24 
months and a serum FSH of 25 or greater. 
 
Subjects randomized by Penn researchers 
83 (to reach final sample of 64 completers) 
 
Subjects enrolled by collaborating researchers 
0 
 
Accrual 
Subjects will be recruited from a database of previous study participants as well as with outreach efforts to the 
university and general community via advertisements, letters and notices. These methods have been 
successful in prior clinical trials.  
 
Key inclusion criteria 
Females, ages 45-65 years in post-menopause, as defined by a history of amenorrhea for a minimum of 24 
months and a serum FSH concentration of 25 mIU/mL and negative pregnancy test 
 
Key exclusion criteria 
Current and prior use of medications known to affect bone (e.g. bisphosphonates, calcitonin, selective 
estrogen receptor modulators, denosumab, diphenylhydantoin, or glucocorticoids) may be considered for 
exclusion, bone mineral density T score of less than -2.5 and greater than +2, vitamin D level less then 12 
ng/ml, BMI of greater than 32, current alcohol or drug abuse (more than 3 alcoholic beverages per day or 
current use of illicit drugs or prescription medications), uncontrolled or untreated cardiac or pulmonary disease, 
liver disease (history of hepatitis or ALT or AST greater than 2x ULN), renal disease (history of renal disease or 
serum creatinine greater than 2x ULN), diabetes, Pacemaker or metallic implants (considered contraindicated 
to MR scanning). 
 
Vulnerable populations 
The following populations are not included in this research study: children, pregnant women, prisoners.  
 
Subject recruitment 
Subjects will be recruited from a database of previous study participants as well as with outreach efforts to the 
university and general community via advertisements, letters and notices. These methods have been 
successful in prior clinical trials.  Additionally, we will use the Penn Clinical Data Warehouse’s (Penn Data 
Store) services. 
 
Study procedures 
Screening visit: Subjects will be scheduled to meet with the study coordinator in the Nutrition and Growth 
Laboratory at Children's Hospital of Philadelphia. The consent form will be reviewed and signed after all 

 
 
 
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questions are answered. Subjects will provide information regarding medical history and current medications. 
Inclusion and exclusion criteria will be reviewed. A urine pregnancy test will be performed. Subjects will 
undergo a DXA of the hip and spine. If total bone mineral density does not indicate osteoporosis (total BMD in 
hip or spine equal to or less than -2.5.), we will proceed with additional screening.  For those who qualify for 
the study based on BMD, blood will be drawn for a comprehensive metabolic panel, 25(OH)D, HgbA1c,TSH 
and FSH and the individual will undergo a pQCT of the tibia. If lab results indicate no evidence of bone disease 
and that the subject is post-menopausal (FSH greater than 25 mlU/mL), a baseline visit will be scheduled.  
 
Baseline visit: Subjects will undergo MRI scans of the tibia and spine taking 60 minutes. It is possible that a 
subject will need to return for a repeat MRI scan if the initial scan is unsatisfactory due to technical reasons. 
Subjects will then be randomized by the device manager to receive an active or placebo Juvent device and will 
be instructed to stand on the device for a 10 minute period daily. To mask the active/placebo status, all devices 
are equipped with a small speaker that emits an audible tone. All subjects will be provided with a supply of 
calcium carbonate and vitamin D3 supplementation. We will dispense 1200 mg/day of calcium carbonate and 
1000 IU/day of vitamin D3 in combined form (soft gel, two pills daily) to be taken by all subjects throughout the 
12 month duration of the trial. 
 
Randomization and blinding: Subjects meeting the entry criteria at the screening visit will be randomly 
allocated 1:1 to an active LMMS or a placebo device. The subjects will then be assigned a treatment number. 
Participant’s names and study numbers will be kept in a password-protected database separate from other 
study records. Random numbers will be generated by a random number generator by the unblinded device 
manager who will maintain a database with even numbers being assigned to treatment and odd numbers to 
placebo. This database will not be shared with the PI or other members of the study team before completion of 
the study. The project manager will be responsible for storing the Juvent devices and the device manager will 
be responsible for dispensing them to the study staff as determined by the randomization number.  
 
Monitoring of adherence: Data stored on the Juvent devices will be collected by the study team during the six 
month visit and twelve month visit via a serial connector.  The study team will be able to monitor the date, time 
and duration of each use. The study coordinator will contact subjects bi-weekly to discuss adherence and to 
provide support. 
 
Six-month visits: Subjects will return to the study site with their Juvent devices. The study team will collect 
study data from the device via a serial connector. The study team will also review medical status, supplement 
compliance and to record any adverse events. Additional calcium carbonate/vitamin D3 will be provided if 
needed.  
 
Twelve-month visit (study completion): Subjects will return to the study site with their Juvent devices. The study 
team will collect study data from the device via a serial connector. Subjects will return for DXA of hip and spine, 
pQCT of the tibia and MRI of tibia and spine, as well as a review of medical status, supplement compliance 
and any adverse events. 
 
Adherence to Study Drugs 
Supplement Accountability and Handling - Calcium Carbonate and Vitamin D3 Supplementation 
We will dispense 1200 mg/day of calcium carbonate and 1000 IU/day of vitamin D3 in combined form (soft gel, 
two pills daily) to be taken by all subjects throughout the 12 month duration of the trial.  Supplements will be 
purchased by the study project manager. Supplements will be purchased based on availability and price. They 
will be shipped directly to the Hospital of the University of Pennsylvania. The supplements will be stored in a 
locked closet in a secured area in the MRI Education center.  Only the study coordinator and study project 
manager will have access to the supplement stock. The dispensing will be conducted by the study coordinator.  
 
At baseline visit each subject will be provided with a six month supply of supplements and asked to take them 
daily. Subjects will be asked to document any missed supplements by noting this in a journal provided by the 
study team. As the study coordinator will call each subject bi-weekly to discuss study progress, any concerns 
or adverse events, subjects will also be asked at this time about supplement compliance. Non-compliant days 

 
 
 
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will be noted by the study coordinator in the subject’s file. At the six month visit subjects will be asked to turn in 
their supplement bottles. The study coordinator will count and record the amount of pills remaining, if any. All 
necessary information will be documented on the dispensing and tracking log. Any remaining supplements will 
be discarded. At the end of this visit the study coordinator will provide each subject with another six month 
supply of supplements to be taken daily as outlined above. When subjects return for the final 12 month visit 
they will be asked to turn in their supplement bottles. The study coordinator will count and record the amount of 
pills remaining, if any. All necessary information will be documented on the dispensing and tracking log. Any 
remaining supplements will be discarded. 
 
Safety issues 
Radiation: This research study involves exposure to radiation from the DXA and pQCT scans and therefore 
subjects will receive a small radiation dose.  This radiation dose is not necessary for medical care and will 
occur only as a result of participation in the study. At doses much higher than subject will receive, radiation is 
known to increase the risk of developing cancer after many years. At the doses subject will receive, it is very 
likely they will see no effects at all.  
 
Blood draw: The blood sampling process infrequently causes pain, bruising, bleeding, vein infection and/or 
vein clotting at the site, and possible fainting. There is little risk in providing five teaspoons of blood in a healthy 
individual.  
 
MRI: The known risks associated with MRI are minimal. MRI uses radio waves and a magnetic field to take 
pictures. The magnet is always on. Some individuals may feel claustrophobic (uncomfortable in small spaces) 
during the MRI scan or may be disturbed by the sounds of the machine, which are loud and repetitive. Any 
metal objects on or inside the body may heat up, move and/or not function properly within the scanning room. 
To minimize any risk from these objects, MRI personnel will screen all subjects. Another risk is that from a 
metallic object flying through the air toward the magnet and hitting the subject. There are many safety 
measures in place to reduce this risk, including screening of all persons and materials entering the scanning 
room. In addition, as the study begins, the door to the room will be closed to minimize the risk of someone 
accidentally walking into or bringing an object into the magnet room. Some of the pulse sequences and/or RF 
coils are not FDA approved but are considered to pose no more than minimal risk. It is possible that during the 
course of the study, the research staff may notice an unexpected finding. Unexpected findings will be 
considered by the appropriate personnel and the PI will inform the subject if necessary. These possible 
findings may or may not be significant and may lead to anxiety. 
 
Reproductive risks: Since DXA and pQCT involve radiation, a negative urine pregnancy test will be required 
before a woman of childbearing potential can participate in this study.  
 
Juvent Vibration Platform: The FDA has designated the risk of the Juvent Vibration Platform as "non-
significant". 
 
Subject confidentiality 
Subjects will be provided with a study ID, which will consist a unique study number and subject ID (e.g. 9943-
001). All patient files will be stored in a locked cabinet in the study coordinator's office. The subject ID will be 
used for all DXA, p-QCT, and MRI studies. 
 
Subject privacy 
HIPPA privacy rules will be observed. Subjects will be interviewed in a private room. All study testing will be 
conducted in closed areas. 
 
Institutional Review Board procedures 
Human research must be reviewed by a convened meeting of the IRB unless the research is determined to be 
exempt or is eligible for expedited review. The final review category and submission requirements will be 
determined by the IRB. The work of reviewing submissions is divided among eight IRBs. IRBs 1 through 5 and 
IRB 7 review general medical research. IRB 8 reviews social and behavioral research. IRB 6 serves 

 
 
 
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Pennsylvania Hospital. If the protocol requires review by the full IRB at a convened meeting, the PI will be 
notified of the assignment of the protocol to an appropriate IRB within two days of receipt by the IRB.  An 
expedited review consists of a review of research involving human subjects by the appropriate IRB executive 
chair or his/her designee.  In reviewing the research, the reviewer may exercise all of the authorities of the 
convened IRB except that the reviewer may not disapprove the research.  Additionally, the reviewer may refer 
the application to the convened IRB for a standard review as warranted.  
 
In general, this assignment will be to the next scheduled meeting of an appropriate IRB (provided that the 
submission is complete). The IRB will review no more than 25 agenda items at each meeting (including new 
submissions, continuing reviews, amendments, unanticipated problems posing risks to subjects or others, or 
previously tabled protocols). Agenda items in excess of 25 will be assigned to the next scheduled meeting of 
an appropriate IRB. 
 
The IRB application for continuing review must be submitted no later than six weeks prior to the expiration date 
for convened board review and no later than two weeks for expedited review. 
 
NOTE: No research related activities may occur after the protocol expiration date unless the PI contacts the 
IRB and the IRB executive chair (or authorized designee) determines that it is in the best interest of subjects to 
continue during the lapse in IRB approval. Federal regulations require that modifications in approved research, 
during the period for which approval has already been given, may not be initiated without prior IRB review and 
approval except where necessary to eliminate apparent immediate hazards to human subjects. Sometimes 
modifications are noted or recognized after they occur. These changes will be reviewed by the IRB as events 
that may represent unanticipated problems involving risks to participants or others and to determine whether 
the change was consistent with ensuring the participants’ continued welfare.  The IRB categorizes 
modifications into three types: amendments, deviations, and exceptions. 
 
Consent process 
The study coordinator will provide a prospective subject with an explanation of the study in person or by phone 
(If possible the coordinator will mail or email the consent to the prospective subject). If the subject verbally 
agrees during the phone screening the study team will then schedule an appointment during which the consent 
will be reviewed and signed after all questions have been answered. A signed copy of the consent form will be 
given to the participant. Informed consent documents will be stored in a secured location where the study team 
only has access to them. If changes are made to the consent or study procedures, participants will be required 
to re-consent. If the subject decides not to participate, they are free to leave the study at any time. Withdrawal 
will not interfere with future care.  
 
Analyses 
Axial stiffness and failure strength: To estimate the axial stiffness of cortical bone (CB), trabecular bone 
(TB) and whole bone (WB) section compressive loading will be simulated in the linear elastic regime. Here, 1% 
axial strain will be applied to the proximal face of the µFE model while keeping the distal face constrained in 
the axial direction while assuming frictionless conditions along the transverse directions. The µFE models will 
then be solved for all three bone-compartments (CB, TB and WB). Axial stiffness is obtained as the ratio of the 
stress on the proximal face to the applied strain. Failure strength will be estimated assuming that bone fails 
when a significant portion (2%) is strained beyond the tissue yield strain chosen as 0.7%. In addition, 3D 
strain-energy maps will be created from upsampled images and histograms generated. 
 
Vertebral bone marrow adiposity: An average fat volume fraction will be computed for each of the five 
lumbar vertebrae as " f =Vf /(Vf +Vw ) where Vf and Vw are the voxel volumes of fat and water, each computed 
as an average of the four central voxels, via Eqs. 1 and 2. Relaxation times for computing saturation factors 
will be mean values obtained from the data collected under Aim 1 in a sub-group of subjects. 
 
Descriptive statistics: To describe participant’s baseline characteristics and study outcome measures at 
baseline and one-year follow-up, data will be recorded overall and within each treatment group. Baseline 
characteristics will include distribution of age, race/ethnicity, adherence data and outcome variables. Summary 

 
 
 
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statistics (standard deviations, medians, and ranges) will be tabulated for all measured variables and their 
frequencies computed. Graphical methods including stem-and-leaf diagrams and box plots will be used to 
examine distributions, identify potential influential points, and guide in the choice of transformations if 
warranted. Baseline measures across the treatment groups will be compared using appropriate 2-sample tests 
including tests, Wilcoxon rank-sum tests and Fisher’s exact tests. All analyses will be conducted using Stata 
9.0 and SAS (for analysis of adherence data) with two-sided tests of hypotheses and a p-value < 0.05 
indicating significance.  Changes in primary and secondary outcomes within patients over the 12-month study 
period will be calculated as differences within subjects and as % changes. 
 
Outcome analyses: All analyses will be done according to the intention to treat principle. The primary 
endpoint is the change in distal tibia trabecular bone whole-section axial failure strength over the 12-month 
study interval. The primary hypothesis to be tested is that treatment with the active LMMS device results in 
greater change in this parameter than treatment with the placebo device over a 12-month period. The 
secondary hypothesis to be tested is that vertebral marrow adiposity is reduced in the treatment relative to the 
control subjects. To evaluate the changes from baseline within groups, 2-sided paired t-tests will be performed 
for both groups. Unpaired t-tests will be used to test the primary and secondary hypotheses that the means of 
the temporal changes are different between treatment groups. Linear regression models will also be 
constructed to compare mean within-subject changes between groups. These models will include differences 
within subjects as the outcome variable, and an indicator variable for treatment group and baseline 
measurement as the covariates. In this manner we will be able to evaluate whether the treatment effect is 
associated with baseline values. Further, since the efficacy of LMMS treatment has been shown to critically 
hinge on adherence, post-hoc analyses will be performed by considering adherence, for example, by excluding 
data from subjects with the lowest quartile of compliance. Lastly, we will examine the hypothesis that the 
treatment effect scales with compliance using regression analysis. 
 
Secondary analyses: Other parameters evaluated comprise various measures of stiffness and strength 
analyzed from the MRI-derived µFE data, as well as structural measures (trabecular parameters of scale and 
topology at the distal site) and bone densitometry quantities, defined previously. Besides axial trabecular 
failure strength and stiffness, these parameters will also be computed for the cortical compartment and whole 
bone (comprising trabecular and cortical bone) at the peripheral location (distal tibia) and the effects compared. 
Since µFE simulations also yield strain energy maps, from histograms of this parameter, means, median and 
mode will be computed as any of these could be more sensitive indicators of treatment than whole-section 
stiffness. Densitometric variables will be evaluated as well for the locations examined (proximal femur and L-
spine by DXA), and distal tibia, and 38% tibial shaft (pQCT). Appropriate adjustments will be made for multiple 
comparisons to account for loss of power. Lastly, associations between baseline parameters as well as 
between the temporal changes in these parameters will be examined by linear regression. 
 
Schedule of visits and evaluations 
 
Visit Description 
 
 
 
 
Study Visits:  
Days or Weeks 
 
 
Screening 
Visit 
 
Additional 
Screening 
*meets 
criteria  
-2.5≤T≤+1 
 
Baseline  
Visit 
 
6 
Month 
Visit 
 
12 
Month 
Visit 
 
 
Study 
Completion 
Informed Consent 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Prior Medications 
X 
 
 
 
 
 
Height 
X 
 
 
 
 
 
Weight 
X 
 
 
 
 
 
Urine Pregnancy Test 
X 
 
 
 
 
 

 
 
 
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DXA Hip and Spine 
X 
 
 
 
X 
 
pQCT 
 
X 
 
 
X 
 
Blood Draw 
 
X 
 
 
 
 
MRI Tibia and Spine 
 
 
X 
 
X 
 
Randomization  
 
 
X 
 
 
 
Subject Instructed to Begin Use 
of Device  
 
 
X 
 
 
 
Data Collection from Device 
 
 
 
X 
X 
 
Start Vitamin D3 and Calcium 
Carbonate  
 
 
X 
 
 
 
Review Medical Status, 
supplement compliance and 
Daily Routine 
 
 
 
X 
X 
 
Adverse Events 
 
X 
X 
X 
X 
X 
Study Completion 
 
 
 
  
 
X 
 
 
Training plan  
All study personnel have completed the CITI training program and certificates are filed in the regulatory 
binders. A delegation of responsibilities log has been created and is also filed in the regulatory binder.  Study 
team meetings will be held regularly at the University of Pennsylvania to assure all study personnel are 
adhering to the protocol. Sub groups will meet as needed. 
 
Recruitment, screening, and eligibility criteria 
We plan to recruit subjects through mass mailings to zip codes within a 30-mile radius of the University of 
Pennsylvania, advertisements in local media, and flyers; methods that have been successful in our prior 
clinical trials. Inclusion criteria will be age 45-65 years and post-menopause, as defined by a history of 
amenorrhea for a minimum of 24 months and a serum FSH concentration of >25 mIU/mL. Exclusion criteria 
will be current or prior use of medications known to affect bone (i.e. bisphosphonates, calcitonin, selective 
estrogen receptor modulators, denosumab, diphenylhydantoin, or glucocorticoids), bone mineral density T 
score of less than -2.5 and greater than +2, vitamin D level less then 12 ng/ml, BMI of greater than 32, current 
alcohol or drug abuse, cardiac, pulmonary, liver, or renal disease or diabetes. Patients meeting the entry 
criteria at the screening or follow-up visit will be randomly allocated 1:1 to an active LMMS or a placebo device.  
 
The PI and study staff will review subject accrual rates and adherence to inclusion/exclusion criteria on a 
monthly basis throughout the recruitment phase. Enrolled subjects who become subsequently ineligible will be 
reported. The recruitment strategies will be adjusted as needed to achieve the target subject characteristics. 
The PI and Safety Officer will review the data bi-annually to ensure that participants meet the goals outlined in 
the grant proposal. 
 
Informed consent and HIPAA   
Informed consent is an ongoing process, which is initiated at the first contact with the potential subject and the 
study team.  The Study coordinator will provide a prospective volunteer with a brief explanation of the study in 
person or over the phone. If interested, the potential subject will schedule an appointment during which the 
combined informed consent and HIPAA authorization form will be reviewed and signed after all questions have 
been answered. 
 
Randomization and blinding/unblinding procedures 
Subjects meeting the entry criteria at the screening visit will be randomly allocated 1:1 to an active LMMS or a 
placebo device. The subjects will then be assigned a treatment number. Subjects name and study number will 
be kept in a password-protected database separate from other study records. Random numbers will be 
generated by a random number generator by the device manager who will maintain a database with even 

 
 
 
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numbers being assigned to treatment and odd numbers to placebo. This database will not be shared with the 
PI or other members of the study team before completion of the study. 
Study Intervention  
 
Active and placebo devices, previously manufactured by Juvent, Inc, will be available from a completed trial on 
children with Crohn’s disease. The FDA has designated the risk pertaining to the device as “non-significant”. 
Subjects will be stimulated mechanically for 10 minutes daily at a frequency of 30 Hz and acceleration of 0.3 g 
(fixed and not alterable by the subject). In a previous clinical trial involving postmenopausal women, there were 
no malfunctions detected during the entire year of the study. Upon their return, recalibration of the devices 
used in that trial showed 98% accuracy relative to start date calibration. To mask the active/placebo status of 
the devices, all devices are equipped with a small speaker that emits a 500 Hz audible tone. Adherence will be 
monitored by an inboard adherence monitor that documents date, time and duration of each use, and the 
adherence data will be transmitted via serial connector to a computer dedicated to this task and supervised by 
study’s project manager. Subjects will also complete a web-based survey two days per week. Adherence 
feedback will be provided to study participants in bi-weekly intervals. Subjects will also be monitored in person 
during the six month and twelve month study visits to review adherence, supplementation compliance and to 
record adverse events.  
 
Participant Retention 
Data adherence with the prescribed LMMS regimen will be collected by the study team during the six month 
visit and the twelve month visit via a serial connector.  The study team will be able to monitor the date, time 
and duration of each use. The Study coordinator will contact the subjects bi-weekly to discuss adherence and 
to provide support. Data will be summarized as the percent of prescribed number of minutes completed 
(percent adherence) in the study subjects. The study coordinator will contact all study subjects that fail to 
maintain an 80% adherence rate in order to identify obstacles to adherence and to develop strategies to 
improve adherence. The coordinator will review these data with the PI and study team on a monthly basis and 
reports will be provided to the safety officer quarterly. 
 
Concomitant Medications 
Patients who currently taking or who have previously taken medications known to affect bone such as 
bisphosphonates, calcitonin, selective estrogen receptor modulators, denosumab, diphenylhydantoin, or 
glucocorticoids will be considered for exclusion excluded from the study. In addition patients currently taking 
illicit drugs or abusing prescription medications will also be excluded.  All medications will be reviewed and 
recorded during the screening visit. Any changes will be recorded at subsequent visits.  The same applies to 
any change of dosage information (dose, frequency, route of administration) or indication. 
 
Safety Reporting 
Reports of any unexpected (headache, dizziness, blurred vision, motion sickness, abdominal pain, nausea, low 
back pain) and serious (events leading to hospitalization or death) adverse events will be prepared by the PI 
and sent to the safety officer, IRB, CTRC and NIAMS within 36 hours. Reports summarizing other adverse 
events will be prepared by the Sstudy coordinator and CTRC informatics and sent to the PI and safety officer 
bi-annually, as follows:   
- 
Subjects will be asked to contact staff with any symptoms or complaints potentially related to the 
use of the LMMS device.   
- 
Subjects will keep a written record of these symptoms or complaints in the same diary in which they 
record instances in which they are unable to use the LMMS device (e.g. vacation, illness).   
- 
Adverse event data that are compiled bi-annually will capture any reported symptoms or complaints 
potentially related to the use of the LMMS device.   
 
An adverse event form has been developed and will be used by the study staff to record any adverse events 
that may be related to the LMMS intervention. The clinical coordinator will prepare a summary of adverse 
events according to subject ID and the study statistician will generate a report of adverse event rates within 

 
 
 
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each study arm. These data will be provided to the PI and safety officer on a bi-annual basis. However, the PI 
and safety officer will remain blinded to treatment assignment unless the safety officer determines it is 
necessary to access this information. 
 
Data and Safety Monitoring Activities 
The monitoring plan includes the case report forms (CRF) and source data verification of efficacy and safety 
parameters, the frequency of monitoring visits, regulatory document review, device accountability and 
compliance review.  Monitoring will be conducted according to the University of Pennsylvania sponsor-
investigator standard operating procedures.   
 
A report schedule has been developed to meet the goals of the DSMP in accordance with NIAMS guidelines.  
The report forms are included below.  The frequency of data review for this study differs according to the data 
type and is summarized in the following table. 
 
Data Safety Monitoring Plan: Report Schedule 
Type of Report: 
Prepared By: 
Provided To: 
Frequency: 
Unexpected and 
Related Serious 
Adverse Events that 
Increase Risk  
PI 
Safety Officer, IRB,     
CTRC, NIAMS 
Within 36 Hours 
Adverse Events 
(combined)  
Clinical Coordinator, CTRC 
Informatics Core 
PI, Safety Officer 
IRB, CTRC 
Every 6 months 
Annually 
Patient Recruitment,     
Targets  
Clinical Coordinator, CTRC 
Informatics Core 
PI 
Safety Officer 
IRB 
Monthly 
Every 6 months 
Annually 
Subject Adherence 
with Intervention 
Clinical Coordinator 
PI 
Safety Officer 
Monthly 
Every 6 months 
Data Quality, 
Deviation from 
Protocol 
Clinical Coordinator, CTRC 
Informatics Core 
PI 
Safety Officer 
IRB 
Monthly 
Every 6 months 
Annually and as 
needed 
Final Analysis: Safety   
and Efficacy 
Statistician  
PI, Safety Officer 
100% accrual and 
follow-up 
 
 
Study Compliance  
The Juvent platforms will collect the study data electronically. The study team will be able to monitor the date, 
time and duration of each use. The study coordinator will contact the subject bi-weekly to discuss adherence 
and to provide support. Adherence data will be collected by the study team via a serial connector and will 
supervised by the study coordinator. Adherence feedback will be provided to study participants in bi-weekly 

 
 
 
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intervals. Subjects will also be monitored in-person during the six month study visit and twelve month study 
visit to review adherence, supplementation compliance and to record adverse events. 
 
Data Flow 
Data will be collected and recorded during each study visit. This will be captured on source documents created 
for this study. All data collected during the course of the study will be entered into the REDcap database. Data 
and form checks/data processing will be conducted to assure completion, consistency and accuracy. The data 
will then be analyzed. Additionally, compliance data downloaded electronically from the Juvent devices will be 
collected and monitored for agreement with study participant self-reporting. 
 
Retention of Study Documentation 
Study records will be retained in accordance with institutional policies.  Currently, the University of 
Pennsylvania requires all study records to be retained for a minimum of seven years after a trial ends.   
 
Data Management 
The computer system that will be utilized for this study will be REDcap. The following functions will be 
supported:  Data tracking, data entry, data editing, updating, reporting and statistical analysis. 
REDCap, a data capture and archiving system, provides protocol-focused data management solutions. 
Developed by Vanderbilt University and implemented by an academic consortium consisting of hundreds of 
academic research institutions, REDCap application's intuitive design and tailored clinical research workflows 
enable a research team to capture and manage data entirely within the research team (i.e., no need for a 
dedicated IT-based data manager). REDCap serves as a more secure and robust alternative to traditional 
Excel and Access databases. 
Quality Control Procedures 
Case report forms will be reviewed by the study coordinator on an ongoing basis for completeness, accuracy 
and documentation. Quality control procedures will include graphical displays of the data to identify outliers and 
case-by-case reviews of data that fall outside of the expected ranges for each variable. Magnetic resonance, 
DXA and pQCT scans will be analyzed and reviewed for quality within three weeks of the study visit. An image 
quality monitoring system has been put in place as a means to evaluate the adequacy of the acquired images 
for analysis. Status of data entry and review will be summarized bi-annually.  A summary of this information will 
be provided in the bi-annual safety reports. Any protocol deviations will be reported to the IRB and a list of 
protocol deviations will be maintained and included with the bi-annual safety reports and annual IRB reports. 
 
Study Completion and Close-out Procedures 
Once the study has been closed to enrollment and all follow-up data have been collected, the study will be 
considered to be in the closeout phase. During this phase, the data will be prepared for final analysis, 
regulatory and reviewing bodies will be notified, the investigational product inventory will be reconciled, and 
final reports will be completed.   
 
Closeout activities include, but are not limited to, the following: 
•  Verification that all study procedures have been completed, data have been entered, and the 
investigational product has been returned to the responsible party. 
•  Verification that all data queries have been resolved. 
•  Assurance that correspondence and study files are accessible for external audits. 
•  Verification that the Penn IRB has been notified of the study’s completion; a copy of the 
notification and any subsequent correspondence will be filed in the study administrative file. 
•   Final reports will be completed. 
 
Participant Notification 
Study participants will be notified that their participation in the study is over at the last visit.  The PI or study 
team member will thank the subject for their participation in the trial. If the participants wish to be informed as 

 
 
 
Page 12 of 12 
 
to the study’s results, a copy of the publication will be mailed or emailed to them, per the participants’ request.     
  
Policies 
 
Confidentiality Procedures 
It is the responsibility of the PI to outline and enforce participant confidentiality and data security guidelines.  
Study staff should be instructed in their responsibilities regarding data safeguards and cautioned against the 
release of data to any unauthorized individuals without checking with the NIAMS.   
 
Participant confidentiality safeguards include: 
• 
Electronic files: Data identifying participants that are stored electronically should be maintained in an 
encrypted form or in a separate file. 
• 
Forms: Forms or pages containing personal identifying information should be separated from other 
pages of the data forms. 
• 
Data listings: Protected health information (such as name, medical record number, etc.) will not be 
included in any published data listing. 
• 
Data disposal: Computer listings that contain participant-identifying information will be disposed of in an 
appropriate manner. 
• 
Access: Participant records will not be accessible to persons outside the site. 
• 
Storage: Study forms and related documents retained both during and after study completion will be 
stored in a secure location. 
 
Additionally, the following elements are required for computer security: 
• 
Passwords: Passwords provide limitations on general access to computer systems and to the functions 
that individuals can use. 
• 
User Training: Study staff with access to clinical computer systems will be trained in their use and in 
related security measures. 
• 
System Testing: Prior to the use of a new computer system, and subsequent to any modifications, the 
system should be tested to verify that it performs as expected. 
• 
System Backups: Backup copies of electronic data should be made at specified intervals.  Backups 
should be stored in file cabinets or secure areas with limited access.   
 
Publication Policy 
The principal investigator will have primary authorship responsibility.  The PI must check with NIAMS if there 
are plans to publish data before the study is over.   
 
 
 
 
 

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UNIVERSITY OF PENNSYLVANIA 
 
RESEARCH SUBJECT INFORMED CONSENT AND HIPAA AUTHORIZATION FORM 
 
 
 
 
Protocol Title:  
Osteoporosis Treatment Response Assessed by 
Micromechanical Modeling of MRI 
 
 
Principal Investigator: 
 
 
 
 
 
Co-Investigator: 
 
 
 
Emergency Contact: 
Felix W. Wehrli, Ph.D.                    215-662-7951 
Department of Radiology 
University of Pennsylvania 
3400 Spruce Street 
Philadelphia, PA 19104 
Peter Snyder, M.D.                         215-898-0208 
Department of Medicine 
University of Pennsylvania 
3400 Civic Center Blvd 
Philadelphia, PA 19104 
Radiology Fellow on Call                 215-662-6059 
 
 
 
 
 
 
 
 
 
You are being invited to participate in a research study.  Your participation is voluntary which 
means you can choose whether or not you want to participate. If you choose not to participate, 
there will be no loss of benefits to which you are otherwise entitled. Before you can make your 
decision, you will need to know what the study is about, the possible risks and benefits of being in 
this study, and what you will have to do in this study. The research team is going to talk to you 
about the research study, and they will give you this consent form to read. You may also decide to 
discuss it with your family, friends, or family doctor. You may find some of the medical language 
difficult to understand. Please ask the research team about this form. If you decide to participate, 
you will be asked to sign this form. 

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Why am I being asked to volunteer? 
 
You are being invited to participate in this research study because you are a healthy, female volunteer 
between the ages of 45-65 years who has not had a period for a minimum of two years. 
 
What is the purpose of this research study? 
 
The purpose of this research study is to gather information about the effects of low-magnitude mechanical 
stimulation (LMMS) on bone using new magnetic resonance imaging (MRI) techniques. LMMS will be 
provided in the form of a Juvent Dynamic Motion Therapy Platform, which looks similar to a large bathroom 
scale. You will stand on the platform for 10 minutes each day.  One half of participating subjects will be 
randomized (like the toss of a coin) to a platform that provides actual vibrations; the other half will use a 
platform that does not provide actual vibrations. The actual vibrations cannot be felt. Neither you nor the 
study staff will know which device you will receive. 
 
How long will I be in the study?  How many other people will be in the study? 
 
One hundred women will participate for a period of one year. 
 
What am I being asked to do? 
 
You will make four visits. The first visit is a screening visit. If you qualify for the study you will return for a 
baseline visit, a six month visit and a twelve month visit. You will be asked to stand on the Juvent Platform for 
a period of 10 minutes each day.  
 
Screening Visit: You will come to The Children’s Hospital of Philadelphia at 3400 Civic Center Boulevard. 
Here you will meet with the study coordinator to review and sign the consent form after all questions and 
concerns have been addressed.  You will provide information about your health and medications, and your 
weight and height will be measured. You will have a urine pregnancy test to document that you are not 
pregnant. You will have a DXA exam. The DXA, or dual-energy X-ray absorptiometry, is a bone density test 
that measures the amount of mineral in your bone. You will lie on a table while the scanner passes over your 
head. If the results of this exam indicate that you do not have osteoporosis in your hip and spine, you will 
have a pQCT of the lower leg. The pQCT is another test for evaluating bone density. Your foot will be placed 
in the scanning machine.  Both DXA and pQCT are non-invasive tests and take about 20-30 minutes to 
complete.  You also will have blood drawn to test for blood chemistries, thyroid hormone, Vitamin D, a test for 
diabetes called hemoglobin A1c and FSH, a hormone that becomes elevated during menopause. The 
purpose of these blood tests is to find out if you have certain conditions that could cause bone disease and to 
confirm that you are postmenopausal. A total of five teaspoons of blood will be collected. 
 
This screening visit should take one and one half to two hours. 
 
Baseline Visit:  If the blood tests show that you are eligible for the study, you will return for an MRI at the 
Hospital of the University of Pennsylvania.  The MRI involves scans of two parts of your body; your spine and 
lower leg. These scans take approximately one hour. You will complete the MRI screening questionnaire to 
make sure that it is safe for you to have an MRI. You cannot have an MRI test if you have a cardiac 
pacemaker or certain types of metal implants or material in your body.  
  
You will go to the MRI suite where you will change into a gown. You will lie on your back on a couch that will 
be moved into the center of the MRI scanner, which is open on both ends. Your whole body, except for your 
head, will be in the scanner. A scan of your lower leg will be performed. The scan involves placing your lower 

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leg in a plastic device that surrounds the lower leg, called a coil.  The scan of your spine requires that you lie 
on your back and go into the scanner head first.  
It is possible that you could be asked to return for a repeat MRI scan if there are technical difficulties with the 
initial scan. 
 
During this visit you will meet with the device manager. The device manager will provide you with a Juvent 
Platform and you will be instructed in its use.  
  
Remember that one half of participating subjects will be randomized (like the toss of a coin) to a platform that 
provides actual vibrations; the other half will use a platform that does not provide actual vibrations. The 
device manager will conduct the randomization. You will first be assigned a treatment number. Your name 
and study number will be kept in a password-protected database separate from other study records. Random 
numbers will be generated by a random number generator. The device manager will maintain a database 
with even numbers being assigned to the vibrating platforms and odd numbers to platforms that do not 
vibrate. This database will not be shared with the PI or other members of the study team before completion 
of the study.  
 
You will be required to stand on the platform for a total of 10 minutes each day. 
  
You should be aware that the study team will be able tomonitor the date, time and duration of each use. 
 
Calcium Carbonate and Vitamin D3 Supplementation 
During the course of the study you will be asked to take 1200 mg/day of Calcium Carbonate and 1000 IU/day 
of Vitamin D3. These supplememts are combined, therefore you will be taking a total of two pills a day. The 
pills are soft gel. 
If you are unable to take the supplements provided due to difficulty swallowing, the study team will work with 
you to provide a different size/quantity of the supplements but with the same dosage.  
 
At this baseline visit the study team will provide you with a supply of calcium carbonate and vitamin D3.  
The study team will also provide you with a journal, we ask that you document any time you miss taking 
these supplements. 
 
This visit will take about two and 1/2 hours. 
 
Study Monitoring:  The study coordinator will contact you either by phone or email (your preferred choice) 
every other week to discuss your daily sessions and any problems you may be having. 
 
Six-Month Visit: You will return to the study site to review your medical status and daily routine. We ask that 
you bring your supplement bottles with you during this visit.  
During this visit the study coordinator will count and record the amount of pills remaining, if any. Remaining 
supplements will be discarded and you will be given a new supply of supplements.   
This visit will take one hour. 
 
Twelve-Month Visit:  You will return to the study site. We will repeat the DXA, pQCT and MRI studies and we 
will update your medical status and daily routine. 
We ask that you bring your supplement bottles with you during this visit.  

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During this visit the study coordinator will count and record the amount of pills remaining, if any. Remaining 
supplements will be discarded. 
This visit will take about three hours. 
 
If you have previous reports/results for DXA, pQCT, blood work, or MRIs, which meet our protocol 
requirements and were conducted within the 60 day window, then these results may be used/collected for 
the study. With your permission, the study team will review these results and decide if they meet study 
requirements. 
 
Survey: So we can actively monitor your study compliance we are asking you to complete a weekly survey 
which will be sent to your email.  In the event you do not have an email or prefer not to use email we will 
review the questions with you by phone. 
 
What are the possible risks or discomforts?  
 
Taking part in a research study involves risks or “side effects.” You should talk about these risks with the 
study staff. There may be side effects we do not know about yet.  
 
MRI:  The known risks associated with MRI are minimal.  MRI uses radio waves and a magnetic field to take 
pictures. The magnet is always on.  Some individuals may feel claustrophobic (uncomfortable in small 
spaces) during the MRI scan or may be disturbed by the sounds of the machine, which are loud and 
repetitive.  We shall provide you with protective earplugs and make every attempt to ensure your comfort 
with blankets, etc. during your time in the scanner.  Any metal objects on or inside your body may heat up, 
move and/or not function properly within the scanning room. 
 
Implanted medical devices and metallic foreign fragments inside your body may pose a risk if you were to enter 
the MRI magnet room.  
Devices such as pacemakers, internal cardiac defibrillators, insulin pumps, and other medical devices may 
also prevent you from safely having the MRI. Therefore, questions regarding medical and work history will be 
asked prior to your exam. 
 
Another risk is that from a metallic object flying through the air toward the magnet and hitting you.  There are 
many safety measures in place to reduce this risk, including screening of all persons and materials entering 
the scanning room.  In addition, as the study begins, the door to the room will be closed to minimize the risk 
of someone accidentally walking into or bringing an object into the magnet room.  
Some of the pulse sequences and/or RF coils are not FDA approved but are considered to pose no more 
than minimal risk. It is possible that during the course of the research study, the research staff may notice an 
unexpected finding.  Should this occur, the finding will be considered by the appropriate personnel and the PI 
will inform you if necessary.  These possible findings may or may not be significant and may lead to anxiety 
about your condition and to further work-up by your physician. 
 
Exposure to Ionizing Radiation from DXA and pQCT: This research study involves exposure to radiation from 
the DXA and pQCT scans and therefore you will receive a small radiation dose.  This radiation dose is not 
necessary for your medical care and will occur only as a result of your participation in the study.  At doses 
much higher than you will receive, radiation is known to increase the risk of developing cancer after many 
years.  At the doses you will receive, it is very likely that you will see no effects at all. 
 
Reproductive Risks: Since the DXA and pQCT involve radiation, a negative urine pregnancy test will be 
required before a woman of childbearing potential can participate in this studyAlthough there are no known 
risks of MRI to a pregnant woman or a fetus, there is a possibility of yet undiscovered pregnancy related 
risks.   

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Blood Draw:  The blood sampling process infrequently causes pain, bruising, bleeding, vein infection and/or 
vein clotting at the site, and possible fainting.  There is little risk of providing 5 teaspoons of blood in a 
healthy individual.  
 
Juvent Platform:  The Food and Drug Administration has designated the risk of this device as "non-
significant". 
 
Privacy and/or Confidentiality:  Every effort will be made to protect your privacy and confidentiality.  However, 
this can not be guaranteed. 
 
We will provide you with copies of the DXA report and the lab test results to review with your doctor if you 
choose. It is possible that during the course of the research study, the research staff may notice an unexpected 
finding(s). Should this occur, the finding(s) will be considered by the appropriate study personnel. We will also 
provide you with a handout created by the study team and completed by the study team that outlines your 
results (both normal and/or abnormal results). We encourage you to discuss any findings with your physican. 
 
What if new information becomes available about the study? 
 
During the course of this study, we may find more information that could be important to you.  This includes 
information that, once learned, might cause you to change your mind about being in the study.  We will notify 
you as soon as possible if such information becomes available. 
 
What are the possible benefits of the study?  
 
There are no direct medical benefits to you if you take part in this study.  
 
What other choices do I have if I do not participate?  
 
You have the choice of not participating in the study. Your current and future medical care at the University of 
Pennsylvania will not be affected if you decide to not take part in this study. 
 
Will I be paid for being in this study? 
 
Yes, Payments will be made by check. You will be paid $xx for the screening visit. If you qualify for the study, 
you will be paid a total of $xx; $xx for the Baseline visit, $xx for the six month visit and $xx for the 12 month 
visit. This payment is to reimburse you for expenses related to participating in the study, such as 
transportation and parking, and to compensate you for the time and inconvenience related to your 
participation.  Please note: In order to be compensated for your participation in this study, you must provide 
your social security number. Additionally, please note that the University of Pennsylvania is required to report 
to the IRS any cumulative payments for participation in research studies that exceed a total of $600 in a 
calendar year. 
 
As previously mentioned the data collected on the Juvent Platforms will allow thestudy team to monitor the 
date, time and duration of each use. A bonus gift valued at $xx (either check or gift card) will be given to all 
subjects that are 100% compliant (stand on device every day for the full 10 minutes).  
 
Will I have to pay for anything? 
 
All study-required procedures will be performed at no cost to you. 
 

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What happens if I am injured or hurt during the study? 
 
We will offer you the care needed to treat injuries directly resulting from taking part in this research.  We may 
bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the 
injury, but you may also be responsible for some of them. There are no plans for the University of 
Pennsylvania to pay you or give you other compensation for the injury.  You do not give up your legal rights 
by signing this form.  If you think you have been injured as a result of taking part in this research study, tell 
the person in charge of the research study as soon as possible.  The researcher’s name and phone number 
are listed on the first page of this consent form. 
 
When is the Study over?  Can I leave the Study before it ends? 
 
This study is expected to end after all participants have completed all visits, and all information has been 
collected.   
The study doctor may take you out of the study at any time and for any reason.  Some of the reasons the 
doctor may take you out of the study include: 
 
o New information suggests that taking part in the study may not be in your best interest. 
o You decide to take back your permission for us to collect, use or share your health information. 
o You have not followed study instructions. 
 
If you decide to participate, you are free to leave the study at any time. Withdrawal will not interfere with your 
future care. 
 
Who can see or use my information? How will my personal information be protected? 
We will do our best to make sure that the personal information obtained during the course of this research 
study will be kept private.  However, we cannot guarantee total privacy.  Your personal information may be 
given out if required by law.  If information from this study is published or presented at scientific meetings, 
your name and other personal information will not be used.   
A description of this clinical trial will be available on <http: //www.clinicaltrials.gov> as required by U.S. law.  
This web site will not include information that can identify you.  At most, the web site will include a summary 
of the results.  You can search this web site at any time. 
 
Electronic Medical Records and Research Results  
 
What is an Electronic Medical Record?  
 
An Electronic Medical Record (EMR) is an electronic version of the record of your care within a health 
system. An EMR is simply a computerized version of a paper medical record.   
If you are receiving care or have received care within the University of Pennsylvania Health System (UPHS) 
(outpatient or inpatient) and are participating in a University of Pennsylvania research study,  results of 
research-related procedures (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in 
your existing EMR maintained by UPHS.   
 
If you have never received care within UPHS and are participating in a University of Pennsylvania research 
study that uses UPHS services, an EMR will be created for you for the purpose of maintaining any results of 
procedures performed as part of this research study. The creation of this EMR is required for your 
participation in this study. In order to create your EMR, the study team will need to obtain basic information 

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about you that would be similar to the information you would provide the first time you visit a hospital or 
medical facility (i.e. your name, the name of your primary doctor, the type of insurance you have). Results of 
research procedures performed as part of your participation in the study (i.e. laboratory tests, imaging 
studies and clinical procedures) may be placed in this EMR. Once placed in your EMR, these results are 
accessible to appropriate UPHS workforce members that are not part of the research team.  Information 
within your EMR may also be shared with others who are determined by UPHS to be appropriate to have 
access to your EMR (e.g. health insurance company, disability provider, etc).  
 
The MRI performed under this protocol is not for medical purposes, and the images are not planned to be 
interpreted by a physician. 
 
Please note that since some study procedures will also be conducted at the Childrens Hospital of 
Philadelphia the CHOP EMR may also capture this information.  
 
 
What personal health information is collected and used in this study, and might also be disclosed? 
The following personal health information will be collected, used for research and may be disclosed or 
released during your involvement with this research study: Name, address, birthdate, telephone number, 
email, medical record number, medical history, current and past medications or therapies, DXA, pQCT, and 
MRI images, and blood test results.  Your social security number is required for payment only and is stored in 
a separate file. 
Research records will be stored in secure areas.  DXA, pQCT and MRI results will be filed using a subject ID 
rather than subject’s name. 
Why is your personal health information being used? 
Your personal contact information is important for the University of Pennsylvania Health System and School 
of Medicine research team to contact you during the study. Your health information and results of tests and 
procedures are being collected as part of this research study.  
 
Which of our personnel may use or disclose your personal health information? 
The following individuals and organizations may use or disclose your personal health information for this 
research project: 
 
- 
The principal investigator and the study team (other university staff associated with the study). 
- 
University of Pennsylvania Office of Regulatory Affairs, (the committee charged with overseeing 
research on human subjects). 
- 
The University of Pennsylvania Office of Human Research (the office which monitors research 
studies). 
- 
Authorized members of the University of Pennsylvania, the University of Pennsylvania Health 
System and the University of Pennsylvania School of Medicine, as well as the Children’s Hospital 
of Philadelphia workforce, who may need to access your information in the performance of their 
duties (for example: to provide treatment, to ensure integrity of the research, scheduling, 
accounting or billing matters, etc.).  
 
Who, outside of the University of Pennsylvania Health System and the School of Medicine, might 
receive your personal health information?  
 
Authorized members of The Children’s Hospital workforce who may need to access your information in the 
performance of their duties. 
 

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As part of the study, the principal investigator may disclose information, including the results of the research 
study tests and procedures to sources outside the Health System, such as for an application for funding, 
journal publications, or scientific posters. 
Results of the study will also be reported to authorized representatives from the NIH (National Institutes of 
Health). 
 
It is possible that authorized members from the Office of Human Research Protection or other governmental 
agencies may want to review the records from this research study. 
In all disclosures outside of the University of Pennsylvania Health System and School of Medicine, you will 
not be identified by name or any other direct personal identifier unless disclosure is required by law. 
The principal Investigator or study staff will inform you if there are any changes to the list above during your 
active participation in the trial.  Once information is disclosed to others outside the University of Pennsylvania 
Health System or School of Medicine the information may no longer be covered by the federal privacy 
protection regulations.   
 
 
How long will the University of Pennsylvania Health System and the School of Medicine be able to 
use or disclose your personal health information?   
Your authorization for use of your personal health information for this specific study does not expire. This 
information may be maintained in a research repository (database). The information collected as part of this 
study may be useful for other studies related to bone disease. We can only use this information again if the 
institutional review board, a committee set up by the University of Pennsylvania to protect the safety and 
privacy of research subjects allows us to do this. The committee may want us to talk to you again before we 
do another study using this information. However, the committee may allow us to use the information again 
without contacting you if we do not use any information that can identify you.  
  
Will you be able to access your records? 
You will be provided with the results of the DXA scan and any blood tests performed. 
 
Can you change your mind? 
 
You may withdraw your permission for the use and disclosure of any of your personal information for 
research, but you must do so in writing to the principal investigator at the address on the first page.  Even if 
you withdraw your permission, the principal investigator for the research study may still use your personal 
information that was collected prior to your written request if that information is necessary to the study. If  you 
withdraw your permission to use your personal health information that means you will also be withdrawn from 
the research study.  
 
Who can I call with questions, complaints or if I’m concerned about my rights as a research subject? 
 
If you have questions, concerns or complaints regarding your participation in this research study or if you 
have any questions about your rights as a research subject, you should speak with the principal investigator 
listed on page one of this form.  If a member of the research team cannot be reached or you want to talk to 
someone other than those working on the study, you may contact the Office of Regulatory Affairs with any 
question, concerns or complaints at the University of Pennsylvania by calling (xxx) xxx-xxxx. 
 
 
 
 

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When you sign this form, you agree to take part in this research study. This means that you have read the 
consent form, your questions have been answered, and you have decided to volunteer.  Your signature 
also means that you are permitting the University of Pennsylvania to use your personal health information 
collected about you for research purposes within our institution. You are also allowing the University of 
Pennsylvania to disclose that personal health information to outside organizations or people involved with 
the operations of this study.  
 
 
 
 
A copy of this consent and HIPPA authorization form will be given to you.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Subject (Print)  
 
 
Signature of Subject   
          Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Person Obtaining 
 
 
Signature                                  
Date 
Consent (Print)