NCT00353080已完成3 期
A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 171
- 试验地点
- 5
- 主要终点
- Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
研究概览
简要总结
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women
To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
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 (Participant, Investigator)
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
- •Ambulatory, healthy postmenopausal women with
- •Natural menopause and more than 5 years after their last menstrual period
- •or surgical menopause and more than 5 years after surgery
- •osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
- •With at least one risk factor for osteoporosis
排除标准
- •Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2
结局指标
主要结局
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
次要结局
- Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
- Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
- Percent changes in bone turnover markers after 12 and 24 months of treatment
- Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
- Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events
研究者
研究点 (5)
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