NCT07909304Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Romosozumab and Denosumab Combination Therapy for Osteoporosis: The ROAD Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
In this research study, the investigators want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT07909304
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Jan 2027 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior exposure to romosozumab
Other
- Current or past use in the 12 months of denosumab
- 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
Who the study is looking for
- 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)
Age in the registry: 45 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.