Efficacy and Safety of MW031 in PMO Subjects

Study Overview
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Brief Summary
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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 .

Official Title
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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

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: MW031
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MW031<br>MW031 injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial, according to the investigator's assessment. | Drug: MW031<br>* The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU<br>* Other names: Recombinant anti-RANKL human monoclonal antibody injection;|
| Placebo Comparator: placebo<br>Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. | Drug: Placebo<br>* subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months | Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment. | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months |  | Baseline and Month 6 | 
| Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months |  | Baseline, Month 6 and Month 12 | 
| Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 12 months |  | Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12 |