To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women

Novartis5 个研究点分布在 5 个国家目标入组 455 人开始时间: 2004年12月1日最近更新: 2012年4月27日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 455
试验地点: 5
主要终点: Temperature increase

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.

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

入排标准

年龄范围: 45 Years 至 75 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
•Low bone mineral density

排除标准

•Certain prior treatments for low bone mass/osteopenia
•Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
•Impaired kidney function
•Other protocol-defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Temperature increase

次要结局

Questionnaires
VAS (visual analog scale)

研究者

发起方

Novartis

申办方类型

Industry

研究点 (5)

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