A Substudy to Explore Biomarkers of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium - Sarcopenia Sub-Study

aboratoires Merck Sharp & Dhome-Chibret0 个研究点目标入组 2,000 人开始时间: 2009年3月19日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Patient is randomized and actively participating (on treatment) in Protocol 018. If the patient is discontinued from Protocol 018 then she can no longer participate in this sub-study.
•2. Patient is willing to participate in the sub-study as indicated by signing the informed consent form for this sub-study. The consent form for this sub-study includes general consent and consent for genetics and RNA testing.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Active conditions that limit general physical strength and function, particularly musculoskeletal in the lower extremities, such as:
•Rheumatoid arthritis, polymyalgia rheumatica, polymyositis, Cushing’s syndrome
•Neuromuscular diseases (i.e. stroke, multiple sclerosis)
•Major surgery in the lower extremities in the past 2 months
•2. Patient has New York Heart Association (NYHA) Class III or IV congestive heart failure

发起方

aboratoires Merck Sharp & Dhome-Chibret