NCT00092079已完成3 期
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 652
- 主要终点
- Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria
研究概览
简要总结
The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or postmenopausal women who are osteoporotic
排除标准
- •Vitamin D deficiency
- •Other disease of bone or mineral metabolism
- •Digestive disease causing malabsorption
- •Other medical conditions that are not adequately treated
结局指标
主要结局
Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)Vitamin D DeficiencyOsteoporosisNCT00092066Organon and Co717
已完成
3 期
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip OsteoarthritisOsteoarthritis, HipNCT00154219Novartis1,200
终止
3 期
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)HIV InfectionNCT00443703Merck Sharp & Dohme LLC352
终止
3 期
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)HIV InfectionNCT00443729Merck Sharp & Dohme LLC355
已完成
3 期
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)Type 2 Diabetes MellitusNCT00482729Merck Sharp & Dohme LLC1,246