DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY ON EFFICACY OF IBANDRONATE

关于伊班膦酸钠疗效的双盲、安慰剂对照、随机研究

• 批准号: 6290933
• 负责人: C. CONRAD JOHNSTON
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6290933
• 关键词: bone fracture; breast neoplasm /cancer diagnosis; clinical research; diphosphonate; drug screening /evaluation; female; human subject; human therapy evaluation; oral administration; osteoporosis; postmenopause; skeletal disorder chemotherapy

The purpose of this three year phase III study is to investigate the therapeutic effect Ibandronate in the long term treatment of postmenopausal osteoporosis by evaluating the efficacy of long term intermittent and long termcontinuous oral treatment using the incidence of new vertebral fractures as the primary endpoint. The specific objectives to determine whether Ibandronate prevents fractures and bone loss in women with established postmenopausal osteoporosis, to determine the type of side effects associated with the oral administration of Ibandronate.

这项为期三年的 III 期研究的目的是调查 伊班膦酸钠长期治疗的疗效 通过评估长期疗效来治疗绝经后骨质疏松症 间歇性和长期连续口服治疗使用的发生率 新的椎体骨折作为主要终点。 具体目标 确定伊班膦酸钠是否可以预防女性骨折和骨质流失 确定绝经后骨质疏松症的类型 与口服伊班膦酸钠相关的副作用。