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Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo/Positive-controlled Phase II Study to Evaluate the Efficacy and Safety of JMT103 in Postmenopausal Women With Osteoporosis

Clinical Trial Summary

This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.

Clinical Trial Description

This study is a randomized, double-blind, placebo/positive-controlled Phase II clinical study to evaluate the efficacy, safety, immunogenicity and pharmacokinetic characteristics of JMT103 in the treatment of postmenopausal women with osteoporosis. Subjects will be screened within -28 days before treatment, and subjects who meet the inclusion/exclusion criteria will be included in the study. The enrolled postmenopausal women with osteoporosis who meet the diagnostic criteria for osteoporosis will be randomized in a 1:1:1:1:1 ratio into Test Group a (JMT103 45 mg group), Test Group b (JMT103 60 mg group), Test Group c (JMT103 90 mg group), Control Group d (denosumab 60 mg group) and Control Group e (placebo group). JMT103,denosumab and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the treatment phase and at 6 months following the initial dose. Each subject will be followed up for 12 months after the first administration. Throughout the research process, subjects will be required to supplement ≥1000 mg of calcium and ≥800 IU of vitamin D every day. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05278338
Study type Interventional
Source Shanghai JMT-Bio Inc.
Contact Rong Du
Phone 0086+010-56081675
Email durong@mail.ecspc.com
Status Recruiting
Phase Phase 2
Start date April 21, 2022
Completion date March 31, 2024
View Details
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