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Completed

NCT Number: NCT05215977

Efficacy and Safety of MW031 in PMO Subjects

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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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MW031

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

Other names: Recombinant anti-RANKL human monoclonal antibody injection

Placebo

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

Primary outcomes

  1. 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

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

    Time frame: Baseline and Month 6

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2022
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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