Efficacy and Safety of MW031 in PMO Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2021-09-27

Brief Summary

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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 .

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MW031

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Recombinant anti-RANKL human monoclonal antibody injection

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No