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

NCT ID: NCT06472050

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2026-03-31

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.

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 at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 [age ≥40 years] or Z scores ≤-3.0 [age <40 years] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).

Of the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.

As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.

Conditions

Osteoporosis; Glucocorticoids Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Romosozumab/denosumab

Romosozumab for 12 months, then denosumab for 36 months

Group Type: ACTIVE_COMPARATOR

Romosozumab

Intervention Type: DRUG

osteoporosis treatment

Denosumab

Intervention Type: DRUG

osteoporosis treatment

Denosumab/denosumab

Densoumab for 48 months

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: DRUG

osteoporosis treatment

Interventions

Romosozumab

osteoporosis treatment

Intervention Type: DRUG

Denosumab

osteoporosis treatment

Intervention Type: DRUG

Other Intervention Names

Evenity (brand names); Prolia (brand name)

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tuen Mun Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chi Chiu Mok

Consultant and honorary professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Chiu Mok, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Tuen Mun Hospital

Locations

Department of Medicine, Tuen Mun Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chi Chiu Mok, MD, FRCP

Role: CONTACT

ccmok2005@yahoo.com

852-37677844

Facility Contacts

Chi Chiu Mok, MD, FRCP

Role: primary

ccmok2006@gmail.com

(852) 2468 5386

Other Identifiers

CIRB-2024-224-3

Identifier Type: -

Identifier Source: org_study_id