Efficacy and Safety of MW031 in PMO Subjects

Mabwell Bioscience

Status and phase: Completed; Phase 3

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Placebo; Drug: MW031

Study type: Interventional

Funder types: Industry

Identifiers

NCT05215977

MW031-2019-CP301

Details and patient eligibility

About

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 .

Enrollment: 448 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 2 patient groups, including a placebo group

MW031

Experimental group

Description:

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.

Treatment:

Drug: MW031

placebo

Placebo Comparator group

Description:

Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Treatment:

Drug: Placebo