RecruitingPhase 3NCT06804590

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

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

278 participants

Start Date

Nov 16, 2024

Study Type

INTERVENTIONAL

Conditions

Postmenopausal Women Osteoporosis

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.

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 9MW0311 and a drug called Prolia® for people with postmenopausal women osteoporosis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG9MW0311

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

DRUGProlia®

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

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NCT06804590