NCT00092027已完成3 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for 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
- 454
- 主要终点
- To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
研究概览
简要总结
This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal 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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with postmenopausal osteoporosis
排除标准
- •High risk for fractures
- •Esophageal abnormalities
- •Upper gastrointestinal symptoms that are not relieved with medication
- •Metabolic bone disease (example - vitamin D deficiency)
- •Medications that would affect the breakdown or build-up of bone
结局指标
主要结局
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
次要结局
- To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
- To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
研究者
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