Postmenopausal OsteoporosisPhase 4NCT07909304
Romosozumab and Denosumab Combination Therapy for Osteoporosis
A Phase 4 study testing Romosozumab and Romosozumab and Denosumab in people with Postmenopausal Osteoporosis, run by Massachusetts General Hospital.
Trial summary
In this research study, the investigators 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 only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Romosozumab and Romosozumab and Denosumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age > 45
- Postmenopausal by either of the following criteria: (1) > 36 months since last spontaneous menses; or (2) > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
- High risk of fracture defined as one of the following: (1) Prior history of osteoporotic fracture, plus hip or spine BMD T-score < -2.0; (2) Hip or spine BMD T-score < -2.5; or (3) 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)
Who cannot join
- Current or past use in the 12 months of denosumab
- Any prior exposure to romosozumab
- Current or use in the past 3 months of estrogens or SERMs
- Current or use in the past 6 months of oral bisphosphonates (BPs) if most recent duration of oral BP use is less than 3 years; or current or use in the past 12 months of oral BPs if most recent duration of oral BP use is 3 years or more
- Current or use in the past 36 months of parenteral BPs
- Current or use in the past 24 months of teriparatide or abaloparatide
- Use of glucocorticoids for more than 14 days consecutively within the past 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Romosozumab and Denosumab Combination Therapy for Osteoporosis: The ROAD Randomized Trial
In this research study, the investigators want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Romosozumab, Romosozumab and 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
Romosozumab and DenosumabDrug
Monthly romosozumab, Every 6 months denosumab
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab and denosumab | Active comparator | Not described Receives: Drug: Romosozumab and 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 posted2 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine W. Yu, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909304
- Sponsor's protocol ID
- 2026P002947
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 41621431Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet. 2013 Jul 6;382(9886):50-6. doi: 10.1016/S0140-6736(13)60856-9. Epub 2013 May 15.
PubMed 23683600
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Romosozumab and Denosumab Combination Therapy for Osteoporosis: The ROAD Randomized Trial
- ClinicalTrials.gov ID
- NCT07909304
- Acronym / sponsor ID
- 2026P002947
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (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, the investigators 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab and denosumab | Active comparator | Drug: Romosozumab and Denosumab |
| Romosozumab | Active comparator | Drug: Romosozumab |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women age > 45
- Postmenopausal by either of the following criteria: (1) > 36 months since last spontaneous menses; or (2) > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
- High risk of fracture defined as one of the following: (1) Prior history of osteoporotic fracture, plus hip or spine BMD T-score < -2.0; (2) Hip or spine BMD T-score < -2.5; or (3) 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)
Key exclusion criteria (7 listed)
- Current or past use in the 12 months of denosumab
- Any prior exposure to romosozumab
- Current or use in the past 3 months of estrogens or SERMs
- Current or use in the past 6 months of oral bisphosphonates (BPs) if most recent duration of oral BP use is less than 3 years; or current or use in the past 12 months of oral BPs if most recent duration of oral BP use is 3 years or more
- Current or use in the past 36 months of parenteral BPs
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 DenosumabMonthly romosozumab, Every 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 3 Nov 2026.
- Background: 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.
- Background: PubMed 23683600Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet. 2013 Jul 6;382(9886):50-6. doi: 10.1016/S0140-6736(13)60856-9. Epub 2013 May 15.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Romosozumab and Romosozumab and Denosumab in people with Postmenopausal Osteoporosis, 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 7 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
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?
Contact Elaine W Yu (617-643-6353, EWYU@mgh.harvard.edu), or a site near the patient. 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 NCT07909304, which also lists 2 linked publications.
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 3 Nov 2026.