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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Bone/metabolic disease
- •Hyperparathyroidism or hypoparathyroidism
- •Thyroid condition: Hyperthyroidism or hypothyroidism
- •Rheumatoid arthritis
- •Malignant tumors
- •Malabsorption syndrome
- •Oral bisphosphonates
研究组 & 干预措施
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.
干预措施: MW031 (Drug)
placebo
Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
时间窗: Baseline and Month 12
Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment.
次要结局
- 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)
- 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)
- Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months(Baseline and Month 6)