Efficacy and Safety of MW031 in PMO Subjects

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .

Inclusion Criteria:

• BMD -4.0<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
• All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
• Postmenopausal is defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea, or bilateral oophorectomy >2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels > 40 mIU/mL to confirm surgical postmenopausal status.

Exclusion Criteria:

• Bone/metabolic disease
• Hyperparathyroidism or hypoparathyroidism
• Thyroid condition: Hyperthyroidism or hypothyroidism
• Rheumatoid arthritis
• Malignant tumors
• Malabsorption syndrome
• Oral bisphosphonates