Efficacy and Safety of MW031 in PMO Subjects

Mabwell (Shanghai) Bioscience Co., Ltd.448 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

448

Conditions

Osteoporosis, Postmenopausal

Interventions

MW031DRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Month 12

Secondary Outcomes

Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months

Time frame: Baseline and Month 6

Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months

Time frame: 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

Time frame: Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12

Data from ClinicalTrials.gov

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