Comparing romosozumab and denosumab for osteoporosis treatment in glucocorticoid users

Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial

This study is testing whether a new treatment plan using romosozumab followed by denosumab can help people with osteoporosis caused by long-term steroid use have stronger bones compared to just using denosumab alone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tuen Mun Hospital (other gov)
• Drugs / interventions: denosumab, romosozumab
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06472050 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the long-term effects of romosozumab followed by denosumab compared to continuous denosumab treatment in patients with glucocorticoid-induced osteoporosis (GIOP). It is an open-label randomized controlled trial that initially assessed bone mineral density (BMD) changes over 24 months and now extends to 48 months to evaluate further BMD changes. Participants are chronic glucocorticoid users at moderate to high risk of fracture, and the study aims to provide insights into the efficacy and tolerability of these treatments over an extended period.

Who should consider this trial

Good fit: Ideal candidates are adults who have been on long-term glucocorticoid therapy and are at moderate to high risk for osteoporotic fractures.

Not a fit: Patients who are not willing to continue denosumab treatment or those who are on other anti-osteoporotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for osteoporosis in patients using glucocorticoids, potentially reducing fracture risk.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this extension study.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Those who are willing to have a repeat DXA assessment at the end of 4 years.

Exclusion Criteria:

1. patients who refuse to be maintained on denosumab after month 24;
2. patients who are maintained on other anti-osteoporotic drugs after month 24; and
3. patients in whom prednisolone is planned to be tapered or discontinued after month 24.

Where this trial is running

Hong Kong

• Department of Medicine, Tuen Mun Hospital — Hong Kong, China (RECRUITING)

Study contacts

• Principal investigator: Chi Chiu Mok, MD, FRCP — Tuen Mun Hospital
• Study coordinator: Chi Chiu Mok, MD, FRCP

Conditions: Osteoporosis, Glucocorticoids Toxicity, glucocorticoids, osteoporosis, fracture, romosozumab, denosoumab, outcome