clinical trial · NCT06804590
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
Mabwell (Shanghai) Bioscience Co., Ltd.·phase3·completed·n = 280
Postmenopausal Women Osteoporosis9MW0311Prolia®
brief 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.
started
Nov 16, 2024
primary completion
Apr 24, 2026
completion
Jun 30, 2026
last updated
Aug 7, 2026
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol