A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk

Mabwell (Shanghai) Bioscience Co., Ltd.1 site in 1 country448 target enrollmentDecember 27, 2019

ConditionsOsteoporosis, Postmenopausal

InterventionsMW031 Placebo

DrugsMW031 Placebo

Overview

Phase: Phase 3
Intervention: MW031
Conditions: Osteoporosis, Postmenopausal
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Enrollment: 448
Locations: 1
Primary Endpoint: Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

December 27, 2019

End Date

September 27, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: MW031

placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months

Time Frame: Baseline and Month 12

Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment.

Secondary Outcomes

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)