NCT00085956已完成3 期
Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
研究概览
简要总结
The purposes of this study are to determine:
- The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
- The effects of arzoxifene on the uterus (womb) in postmenopausal women.
- The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
- The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
- The safety of arzoxifene and any side effects that might be associated with its use.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45 to 60 years of age, inclusive
- •At least 2 years since last menstrual cycle
- •Intact uterus (womb).
排除标准
- •Existing fracture of the spine.
- •Bone disorders, other than low bone mass
- •History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
- •Abnormal or unexplained vaginal bleeding.
结局指标
主要结局
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
次要结局
- The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
- The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
- The effects of arzoxifene on breast density
研究者
研究点 (1)
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