NCT00143273已完成2 期
Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 1
- 主要终点
- Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
研究概览
简要总结
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal Asian women with osteoporosis defined by low BMD
排除标准
- •Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
研究组 & 干预措施
Lasofoxifene Dose 1
Experimental
0.05 mg
干预措施: Lasofoxifene (Drug)
Lasofoxifene Dose 2
Experimental
0.25 mg
干预措施: Lasofoxifene (Drug)
Lasofoxifene Dose 3
Experimental
0.5 mg
干预措施: Lasofoxifene (Drug)
Placebo
Placebo Comparator
0 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
时间窗: 12 months
Percent change from baseline in lumbar spine BMD at Month 12
次要结局
- Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year(Month 6 and Month 12)
研究者
研究点 (1)
Loading locations...
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