Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
详细描述
The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal osteoporosis under densitometric criteria of the World Health Organization
排除标准
- •secondary osteoporosis
- •alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
研究组 & 干预措施
alendronate 6 years
干预措施: alendronate (Drug)
alendronate 5 years
No treatment during year 6th
干预措施: alendronate (Drug)
alendronate 5 years, not continued
No treatment during year 5th
干预措施: alendronate (Drug)
alendronate 4 years
No treatment during year 5th and 6th
干预措施: alendronate (Drug)
alendronate 5 years, uncontinued
No treatment during year 4th
干预措施: alendronate (Drug)
alendronate 4 years, not continued
No treatment during year 4th and 6th
干预措施: alendronate (Drug)
alendronate 4 years, uncontinued
No treatment during year 4th and 5th
干预措施: alendronate (Drug)
Alendronato 3 years
No treatment during the last 3 years
干预措施: alendronate (Drug)
结局指标
主要结局
Bone mineral density
时间窗: Every year
次要结局
- Fractures(Every year)