An Observational Follow-Up Study for: A 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 (Protocol 018) - An Observational follow-up study to Protocol 018

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 7,745 人开始时间: 2014年10月7日最近更新: 2016年10月17日

研究概览

暂无简介。

•In order to be eligible for participation in this trial, the subject must:
•1.Have been randomized into Protocol 018
•2.Have taken at least 1 dose of blinded study medication
•3.Have discontinued from Protocol 018 base study prior to study close-out OR have completed the base study of Protocol 018 and did not continue into the 1st extension of Protocol 018 OR have discontinued the 1st extension study (Protocol 018-10/Protocol 018-05) prior to reaching the open-label portion of the study OR have discontinued the amended 1st extension study (Protocol 018-06) prior to reaching the open-label period of the study and did not consent to continue follow-up clinic visits and study procedures.
•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 6000

•The subject must be excluded from participating in the trial if the subject:
•1.Had her Protocol 018 treatment group assignment unblinded, prior to the open-label period
•2.Has discontinued treatment after she entered into the open-label period

发起方