A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.

Sanofi0 个研究点开始时间: 1999年8月最近更新: 2011年1月11日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi
主要终点: To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.

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 primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic 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: None

入排标准

年龄范围: 65 Years 至 80 Years（Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Ambulatory women,
•Caucasian, Oriental or Multiracial
•not previously diagnosed for osteoporosis.

排除标准

•Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
•and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.

时间窗: collected at week 10 and 22

次要结局

to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis(During the study conduct)
to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)(after 10 and 22 weeks of treatment)
To assess the change in BMD of both total hip and lumbar spine;(at week 52 compared to baseline)
osteoporosis-related genotyping.(During the study conduct)

研究者

发起方

Sanofi

申办方类型

Industry

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