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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MW031 | Experimental | 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. |
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| placebo | Placebo Comparator | Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MW031 | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Hospital | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38752402 | Derived | Jiang Y, Huo Y, Li Y, Kong X, Wang B, Liu F, Zheng X, Li Y, Yang Y, Xu Y, Xue Q, Hu Z, Xiao Y, Ma W, Guo Y, Yu W, Xia W. Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Drug | 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 |
|
| 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 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |