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RECRUITING
NCT06804590
PHASE3

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

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

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

Key Details

Gender

FEMALE

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

278

Start Date

2024-11-16

Completion Date

2026-07-30

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

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.

Locations (1)

Mabwell (Shanghai) Bioscience Co., Ltd.

Beijing, China