Efficacy and Safety of MW031 in PMO Subjects

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215977
• Other study ID #: MW031-2019-CP301
• Status: Completed
• Phase: Phase 3
• Start date: December 27, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: October 2023
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• MW031
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
• Placebo
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

Locations

Country	Name	City	State
China	Peking Union Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Month 12
Secondary	Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months		Baseline and Month 6
Secondary	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
Secondary	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