NCT06804590

A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis

A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.

Detailed description

278 patients are randomized 1:1 to receive 9MW0311 and Prolia® every 6 months for 12 months. The primary efficacy endpoint is the percentage change from baseline in BMD at the lumbar spine(LS) in month 12.

Conditions

• Postmenopausal Women Osteoporosis

Interventions

Type	Name	Description
DRUG	9MW0311	9MW0311 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
DRUG	Prolia®	Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Timeline

• Start date: 2024-11-16
• Primary completion: 2026-04-30
• Completion: 2026-07-30
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

1 site across 1 country: China