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

Registration Number
NCT06472050
Lead Sponsor
Tuen Mun Hospital
Brief 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 spin...

Detailed Description

The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by ...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
63
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Romosozumab/denosumabRomosozumabRomosozumab for 12 months, then denosumab for 36 months
Romosozumab/denosumabDenosumabRomosozumab for 12 months, then denosumab for 36 months
Denosumab/denosumabDenosumabDensoumab for 48 months
Primary Outcome Measures
NameTimeMethod
change in BMD at the lumbar spine24 more months after RCT completion

spine BMD

Secondary Outcome Measures
NameTimeMethod
change in BMD at non-dominant hip and femoral neck24 more months after RCT completion

hip and femoral neck BMD

Trial Locations

Locations (1)

Department of Medicine, Tuen Mun Hospital

🇨🇳

Hong Kong, China

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