A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,600
- 试验地点
- 6
- 主要终点
- Incidence of vertebral fracture
研究概览
简要总结
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis.
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
A total of 7180 subjects were randomized to the romosozumab 210 mg QM (3589 subjects) and placebo (3591 subjects) groups. Of the 7180 randomized subjects, 6045 completed the 24-month study period and entered the 12-month extension period. Of the 7180 randomized subjects, 80% of the subjects completed the 36-month study period (romosozumab/denosumab, 79.4%; placebo/denosumab, 80.5%). Throughout the study, withdrawn consent was the most frequently reported reason for discontinuation from study in both treatment groups (romosozumab/denosumab, 10.9%; placebo/denosumab, 9.8%). Overall during the 36-month study period, 79.0% of subjects completed investigational product administration (romosozumab/denosumab, 78.2%; placebo/denosumab, 79.8%).
Throughout the study, withdrawn consent was the most frequently reported reason for discontinuation of investigational product (romosozumab/denosumab, 9.9%; placebo/denosumab, 8.8%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women osteoporosis, defined as low bone mineral density.
排除标准
- •Severe osteoporosis Use of agents affecting bone metabolism History of metabolic or bone disease (except osteoporosis) Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) Current hyper- or hypocalcemia Current, uncontrolled hyper or hypothyroidism Current, uncontrolled hyper or hypoparathyroidism.
结局指标
主要结局
Incidence of vertebral fracture
时间窗: [ Time Frame: 12 Months, 24 Months ] [ Designated as safety issue: No ]
次要结局
- Incidence of Fracture([ Time Frame: 12 Months ] [ Designated as safety issue: No ])
- Changes In Bone Mineral Density from Baseline to 12 Months([ Time Frame: 12 Months ] [ Designated as safety issue: No ])
- Changes In Bone Mineral Density from Baseline to 24 Months([ Time Frame: 24 Months ] [ Designated as safety issue: No ])