Postmenopausal OsteoporosisPhase 4NCT05010590
Anabolic Therapy in Postmenopausal Osteoporosis
A Phase 4 study testing Romosozumab and Denosumab in people with Postmenopausal Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis. 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
- Postmenopausal Osteoporosis
- What is being tested?
- Romosozumab and Denosumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 1 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Postmenopausal women at high risk of fracture
Who cannot join
- Prior therapy exclusions
- current use or use in the past 12 months of oral bisphosphonates or denosumab
- current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
- use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- any current or previous use of romosozumab or strontium
- current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.
Show all 27Show fewer
- Other exclusions
- Confirmed serum alkaline greater than 2 times the upper normal limit.
- Stage 4 or 5 chronic kidney disease (GFR less than 30)
- Hypercalcemia (Ca greater than 10.5 mg/dL)
- Hypocalcemia (Ca less than 8.8 mg/dL)
- Elevated blood PTH (intact PTH greater than 77 pg/mL)
- Serum 25-OH vitamin D less than 20 ng/mL
- HCT less than 32%.
- History of malignancy (except basal cell carcinoma).
- Significant pulmonary disease
- History of myocardial infarction or stroke within the preceding year.
- History of unstable angina or transient ischemic attack in the past year.
- Current atrial fibrillation.
- Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
- Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Uncontrolled eczema
- Congenital or acquired bone disease other than osteoporosis.
- Known sensitivity to denosumab or any of its excipients.
- Known sensitivity to romosozumab or any of its excipients.
- History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Romosozumab, Denosumab
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Monthly romosozumab
DenosumabDrug
Every 6 months denosumab
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab and denosumab | Active comparator | Not described Receives: Drug: Romosozumab; Drug: Denosumab |
| Romosozumab | Active comparator | Not described Receives: Drug: Romosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hip areal bone mineral density
Change in total hip bone density between month 0 and month 12
Measured: Month 0 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start24 Mar 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Leder, MD, Massachusetts General Hospital
- Investigators
- Benjamin Leder, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010590
- Sponsor's protocol ID
- 2021P002125
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Leder BZ, Ramchand SK, Jordan M, Ryan S, Patnaik A, Lee H, Tsai JN. 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Mar;14(3):216-222. doi: 10.1016/S2213-8587(25)00319-5. Epub 2026 Jan 29.
PubMed 41621431
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Therapy in Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT05010590
- Acronym / sponsor ID
- 2021P002125
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Aug 2021 (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.
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab and denosumab | Active comparator | Drug: Romosozumab, Drug: Denosumab |
| Romosozumab | Active comparator | Drug: Romosozumab |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women at high risk of fracture
Key exclusion criteria (27 listed)
- Prior therapy exclusions
- Other exclusions
- Confirmed serum alkaline greater than 2 times the upper normal limit.
- Stage 4 or 5 chronic kidney disease (GFR less than 30)
- Hypercalcemia (Ca greater than 10.5 mg/dL)
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 |
|---|---|---|
| RomosozumabMonthly romosozumab | Drug | Romosozumab, Romosozumab and denosumab |
| DenosumabEvery 6 months denosumab | Drug | Romosozumab and denosumab |
Primary outcome
Total hip areal bone mineral density
Time frame: Month 0 to 12
Change in total hip bone density between month 0 and month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 41621431Leder BZ, Ramchand SK, Jordan M, Ryan S, Patnaik A, Lee H, Tsai JN. 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Mar;14(3):216-222. doi: 10.1016/S2213-8587(25)00319-5. Epub 2026 Jan 29.
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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.
Benjamin Leder, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Romosozumab and Denosumab in people with Postmenopausal Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Total hip areal bone mineral density (time frame: Month 0 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010590, which also lists 1 linked publication.
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 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.