Osteoporosis, PostmenopausalPhase 4NCT03232476
Effect of Mechanical Loading With PTH on Cortical Bone
A Phase 4 study testing Upper extremity voluntary loading in people with Osteoporosis, Postmenopausal, run by Massachusetts General Hospital.
Trial summary
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Upper extremity voluntary loading
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Who cannot join
- no significant previous use of bone health modifying treatments
About this study
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Upper extremity voluntary loading
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity voluntary loadingDevice
Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.
| Study group | Role | What they receive |
|---|---|---|
| Loaded upper extremity | Other | This is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control. Receives: Device: Upper extremity voluntary loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
radius bone mineral density
Measured: 12 month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Unsuccessful recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Tsai, Massachusetts General Hospital
- Investigators
- Joy Tsai, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232476
- Sponsor's protocol ID
- 2017P001094
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2017
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Loading With PTH on Cortical Bone
- ClinicalTrials.gov ID
- NCT03232476
- Acronym / sponsor ID
- 2017P001094
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unsuccessful recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loaded upper extremity | Other | Device: Upper extremity voluntary loadingThis is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Key exclusion criteria (1 listed)
- no significant previous use of bone health modifying treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper extremity voluntary loadingSubjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day. | Device | Loaded upper extremity |
Primary outcome
radius bone mineral density
Time frame: 12 month change
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy Tsai, MD principal investigator
MGH
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Upper extremity voluntary loading in people with Osteoporosis, Postmenopausal, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radius bone mineral density (time frame: 12 month change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.