drugset / Trial / NCT06472050

Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months

NCT06472050

Phase 4 Completed 54 enrolled Tuen Mun Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-08-20
Primary completion
2025-12-15
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody
Comparator Romosozumab Monoclonal antibody

Indications