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