NCT00383422已完成3 期
The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis
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
- 320
- 试验地点
- 1
- 主要终点
- Percent change in Lumbar Spine BMD
研究概览
简要总结
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have osteoporosis
- •Must be between 50 and 75 years old and be able to walk
- •Have at least two of your back bones that can be x-rayed
- •Have not had a period in at least two years
- •Be willing to have blood tests
排除标准
- •Have a bone disease other than osteoporosis
- •History of estrogen dependent cancer
- •History of stroke or certain heart problems
- •Possibly have an allergy to raloxifene or arzoxifene
- •Have certain abnormal lab values
- •History of seizure disorder
- •Have unexplained vaginal bleeding or an abnormal pap smear
研究组 & 干预措施
1
Experimental
干预措施: Arzoxifene (Drug)
2
Active Comparator
干预措施: Raloxifene (Drug)
结局指标
主要结局
Percent change in Lumbar Spine BMD
时间窗: baseline to 12 months
次要结局
- Breast Density by mammogram(screening and 12 months)
- Secondary BMD measures of total hip and femoral neck(at 6 and 12 months)
- Biochemical markers of bone metabolism assessed(baseline, 3, 6, and 12 months)
- Assessment of coagulation parameters(baseline, 3, 6, and 12 months)
研究者
研究点 (1)
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