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

NCT06472050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Romosozumab

osteoporosis treatment

DRUG

Denosumab

osteoporosis treatment

Sponsors & Collaborators

  • Tuen Mun Hospital

    lead OTHER_GOV

Principal Investigators

  • Chi Chiu Mok, MD, FRCP · Tuen Mun Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2025-12-15
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06472050 on ClinicalTrials.gov