Back to results

Efficacy and Safety of MW031 in PMO Subjects

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

MW031

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Peking Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MW031

placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05215977

First Posted

January 18, 2022

Last Updated

October 8, 2023

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05215977

Brief Title

Efficacy and Safety of MW031 in PMO Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

December 27, 2019 (Actual)

Primary Completion Date

September 27, 2021 (Actual)

Study Completion Date

September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

448 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MW031

Arm Type

Experimental

Arm 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.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MW031

Other Intervention Name(s)

Recombinant anti-RANKL human monoclonal antibody injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline and Month 12

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline and Month 6

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Peking Union Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Safety of MW031 in PMO Subjects

We'll reach out to this number within 24 hrs