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RECRUITINGPhase 4INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Romosozumab

osteoporosis treatment

DRUG

Denosumab

osteoporosis treatment

Locations (1)

Department of Medicine, Tuen Mun Hospital
Hong Kong, China