NCT00398606已完成3 期
A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis 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
- 650
- 主要终点
- BMD of the lumbar spine determined by a DEXA scan at 2 years
研究概览
简要总结
The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis
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
- 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
- •Patient is postmenopausal (or surgically menopausal) for at least 5 years.
- •Patient must be diagnosed with osteoporosis
- •Patient has spinal anatomy suitable for DEXA of the lumbar spine
排除标准
- •Patient is receiving or has received treatment prior to randomization which might influence bone turnover
- •Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
- •Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
结局指标
主要结局
BMD of the lumbar spine determined by a DEXA scan at 2 years
次要结局
- BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years
研究者
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