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

Organon and Co0 个研究点目标入组 717 人开始时间: 2003年9月24日最近更新: 2024年8月14日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 717
主要终点: Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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 the 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 significant medical conditions that are not adequately treated

结局指标

主要结局

Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.

次要结局

Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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