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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Medicine, Tuen Mun Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Chi Chiu Mok, MD, FRCP
ccmok2005@yahoo.com
852-37677844
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 63
Treatments
Active_comparator: Romosozumab/denosumab
Romosozumab for 12 months, then denosumab for 36 months
Active_comparator: Denosumab/denosumab
Densoumab for 48 months
Related Therapeutic Areas
Sponsors
Leads: Tuen Mun Hospital

This content was sourced from clinicaltrials.gov