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RECRUITING
NCT06472050
PHASE4

Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study

Sponsor: Tuen Mun Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2024-08-20

Completion Date

2026-03

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DRUG

Romosozumab

osteoporosis treatment

DRUG

Denosumab

osteoporosis treatment

Locations (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, China