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.
Women who can walk freely (≥50 and ≤80 years);
As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0<T value ≤-2.5;
Subjects must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a history of hip fragility fracture; 3) Increased bone turnover rate during screening; 4) Low body weight; 5) Old age(≥70); 6) Currently smoking.
The duration of spontaneous amenorrhea was >2 years or >2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels >40mIU/mL may be used to confirm the status of postoperative menopause.
Bone/metabolic disease
Hyperparathyroidism or hypoparathyroidism
Thyroid condition: Hyperthyroidism or hypothyroidism
Rheumatoid arthritis
Parallel
9MW0311
Drug9MW0311 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
Prolia®
DrugProlia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
Percent Change From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12)
Percent Change From Baseline in LS-BMD at Week 53 （Month 12)
Percent Change From Baseline in LS-BMD at Week 27 （Month 6)
Percent Change From Baseline in LS-BMD at Week 27 （Month 6)
Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )
Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months
Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)
Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)
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