NCT06472050CompletedPhase 4
Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months
Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 9 Jun 2024
- Start date
- 20 Aug 2024
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Tuen Mun Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT06472050
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 54
- From 20 Aug 2024 to the primary completion date, 15 Dec 2025
- 1 site in 1 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
- patients who are maintained on other anti-osteoporotic drugs after month 24; and
Other
- patients who refuse to be maintained on denosumab after month 24;
- patients in whom prednisolone is planned to be tapered or discontinued after month 24.
Who the study is looking for
- patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT
- Those who are willing to have a repeat DXA assessment at the end of 4 years.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medicine, Tuen Mun Hospital Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.