Efficacy and Safety of MW031 in PMO Subjects

• Status: Completed
• Trial end date: 2021-09-27
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• BMD -4.0- 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