EUCTR2008-004578-42-DK进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Participant is already enrolled in Protocol 018.
- •2. Participant is willing to undergo all imaging procedures and bone biopsies.
- •3. Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures).
- •4. Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. Significant scoliosis, bone deformity, and sequelae of orthopedic procedures that result in unsuitable anatomy must be absent from the lumbar spine. At least two vertebrae from L1-L4 must be evaluable.
- •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
排除标准
- •1. Participant has a history of tremors, Parkinson's disease, multiple sclerosis or other diseases that cause persistent tremors.
- •2. Participant is unable to take a bone-labeling agent (e.g., demeclocycline or tetracycline).
- •3. Participant has a past medical history of clotting or bleeding disorders.
- •4. Participant is unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.
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