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

NCT06472050 | Completed Phase 4

• 1 other identifier: CIRB-2024-224-3
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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 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

Osteoporosis; Glucocorticoids Toxicity

Keywords

glucocorticoids; osteoporosis; fracture; romosozumab; denosoumab; outcome

Outcome Measures

Primary Outcomes (1)

• change in BMD at the lumbar spine

  spine BMD

  24 more months after RCT completion

Secondary Outcomes (1)

• change in BMD at non-dominant hip and femoral neck

  24 more months after RCT completion

Study Arms (2)

Romosozumab/denosumab

ACTIVE COMPARATOR

Romosozumab for 12 months, then denosumab for 36 months

Drug: Romosozumab; Drug: Denosumab

Denosumab/denosumab

ACTIVE COMPARATOR

Densoumab for 48 months

Drug: Denosumab

Interventions

Romosozumab DRUG

osteoporosis treatment

Also known as: Evenity (brand names)

Romosozumab/denosumab

Denosumab DRUG

osteoporosis treatment

Also known as: Prolia (brand name)

Denosumab/denosumab; Romosozumab/denosumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Interventions

romosozumab; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chi Chiu Mok, MD, FRCP

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and honorary professor

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 24, 2024
• Study Start: August 20, 2024
• Primary Completion: December 15, 2025
• Study Completion: April 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)