Efficacy and Safety of MW031 in PMO Subjects

Phase 3

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Placebo; Drug: MW031

• Registration Number: NCT05215977
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-27
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 448

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
MW031	MW031	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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 BMD at the Lumbar Spine from Baseline up to 6 months	Baseline and Month 6

Trial Locations

Locations (1)

Peking Union Hospital; 🇨🇳 Beijing, Beijing, China