NCT00384072已完成3 期
A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Wyeth is now a wholly owned subsidiary of Pfizer20 个研究点 分布在 3 个国家目标入组 500 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
研究概览
简要总结
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of 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
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
- •Subjects must qualify for one of the following categories (a or b):
- •Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
- •Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor
排除标准
- •One (1) or more osteoporotic vertebral fractures (T4 - L4)
- •BMD T-score at the lumbar spine or femoral neck less than -2.5
- •Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
结局指标
主要结局
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
次要结局
- Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
- Serum bone markers at 3 and 6 months
- Lipid profile at 3 and 6 months
研究者
研究点 (20)
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