NCT00163137已完成3 期
Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Spine BMD after 2 years
研究概览
简要总结
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
排除标准
- •Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
- •Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
研究组 & 干预措施
Lasofoxifene 0.25 mg
Experimental
lasofoxifene 0.25 mg/day
干预措施: lasofoxifene (Drug)
raloxifene
Active Comparator
raloxifene 60 mg/day
干预措施: raloxifene (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Spine BMD after 2 years
时间窗: 2 years
Lumbar Spine Bome Mineral Density
次要结局
- Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year(Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months)
研究者
研究点 (1)
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