CompletedPhase 4

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

China54 participantsStarted 2024-08-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

change in BMD at the lumbar spine

Timeframe: 24 more months after RCT completion

Trial details

NCT IDNCT06472050

SponsorTuen Mun Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-15

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