An Imaging Sub-Study of 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 - The Imaging Sub-study for the Fracture Trial

Merck & Co., Inc.0 个研究点目标入组 164 人开始时间: 2009年10月21日最近更新: 2019年6月30日

研究概览

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•1. Participant is already enrolled in Protocol 018.
•2.Participant is willing to undergo all QCT and DXA imaging procedures and biomarker assessments.
•3. Participant's body habitus allows for QCT scanning (i.e. Body Mass Index (BMI) is = 35 kg/m2).
•4.Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures). Note: Surgical clips are acceptable.5.Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. (e.g. does not have significant scoliosis, bone deformity, hardware or sequelae of orthopedic procedures. Note: Surgical clips are acceptable.) For DXA, at least 2 vertebrae from L1-L4 must be evaluable and for QCT, at least 2 vertebrae from T12-L3 must be evaluable.
•6. Participant understands the study procedures and the risks involved with the study and voluntarily agrees to participate by giving written informed consent.
•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. Participant has a history of tremors, Parkinson's disease, multiple sclerosis or other diseases that cause persistent tremors.
•2.Participant is unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.
•3. Participant baseline QCT imaging scan, of the hip or spine, is of insufficient quality, as confirmed by the central imaging vendor.

发起方