Clinical Trial

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

Completed Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-08
minor Completion moved earlier: 2026-07-30 -> 2026-06-30 2026-08-08
Trial Details
NCT Number NCT06804590
Lead Sponsor Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions Postmenopausal Women Osteoporosis
Enrollment 280 participants
Start Date 2024-11-16
Primary Completion 2026-04-24 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-07