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Efficacy and Safety of MW031 in PMO Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of MW031 in PMO Subjects

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

NCT05215977•Mabwell (Shanghai) Bioscience Co., Ltd.

View on ClinicalTrials.gov

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 .

Eligibility

Age

55 - 80 years

Sex

FEMALE

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

Locations (1)

Peking Union Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 27, 2019

Primary Completion Date

September 27, 2021

Completion Date

September 27, 2021

Last Updated

October 11, 2023

Enrollment

448

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

MW031

DRUG

Placebo

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

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RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of MW031 in PMO Subjects

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women