Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Randomized Controlled Trail At 6 Years

NCT07757373 | Not Yet Recruiting Phase 4

• 1 other identifier: CIRB-2026-PENDING
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is an extended observation study of a RCT comparing the efficacy of romorozumab and denosumab in high-risk patients using long-term glucocorticoids. In the romosozumab arm, patients were shifted to denosumab after the first year. The denosumab arm of patients were continued on denosumab. This study aims to look at the bone mineral density changes in both groups of patients after 6 years.

Conditions

Glucocorticoid-Associated Osteopenia and Osteoporosis

Keywords

glucocorticoids; bone mineral density; romosozumab; denosumab

Outcome Measures

Primary Outcomes (1)

• Bone mineral density at year 6

  6 years

Study Arms (2)

romosozumab

ACTIVE COMPARATOR

romosozumab for 12 months, followed by denosumab

Drug: Romosozumab; Drug: Denosumab

denosumab alone

ACTIVE COMPARATOR

Drug: Denosumab

Interventions

Romosozumab DRUG

romosozumab for 12 months, followed by denosumab

romosozumab

Denosumab DRUG

demonsumab

denosumab alone; romosozumab

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 48; (2) those who are willing to have a repeat DXA assessment at the end of 6 years

You may not qualify if:

• patients who refuse to be maintained on denosumab after month 48
• patients who are maintained on other anti-osteoporotic drugs after month 48
• patients in whom prednisolone is planned to be tapered or discontinued after month 48.

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

romosozumab; Denosumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Chi Chiu Mok, MD, FRCP

CONTACT

24685111; ccmok2006@gmail.com

becky Fong

CONTACT

37673430; becky_fongls@yahoo.com.hk

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

Model Details: intervention: romosozumab followed denosumab versus denosumab alone

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)