A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy - Evaluate Safety Efficacy Denosumab Actonel Therapies in PMO

Amgen0 个研究点目标入组 98 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Ambulatory, postmenopausal women (based) on medical history) aged 55 years or older at screening :
•-postmenopause will be defined as no vaginal bleeding or spotting for a least 12 months
•2. received at least 1 prescription of oral alendronate therapy (weekly or dialy) as a first treatment for post menopausal osteoporosis in the 18 months prior to screening. Use of raloxifene, calcitonin or HRT prior to alendronate treatment will be allowed. Prior and/or current use of vitamin D and calcium will be allowed.
•3,Subject has demonstrated 1 of the following :
•-has stopped oral alendronate therapy (is denoted as non-persistent) at least one month before the screening visit
•-is still taking oral alendronate therapy but demonstrates low adherence to therapy assessed by a score of less than 6 on the Osteoporosis Specific Morisky Medication Adherence Scale(OS-MMAS)
•4.Provide signed informed consent before any study-specific procedures are conducted

•1. any prior or current use of medications prescribed for osteoporosis treatment other than: oral daily or weekly alendronate, calcium and vitamin D
•prior use of raloxifene, calcitonin or HRT before alendronate therapy was initiated will be allowed. Use of these therapies must have stopped prior to initiating oral alendronate and their current use is not allowed.;Any prior or current use of medications prescribed for osteoporosis treatment other than:
•-oral daily or weekly alendronate, calcium and vitamin D
•prior use of raloxifene, calcitonin, or HRT before alendronate therapy was initiated will be allowed. Use of these therapies must have stopped prior to initiating oral alendronate and their currentn use is not allowed

发起方