NCT03219125已完成不适用
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2018年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Bone marrow fat content at lumbar spine
研究概览
简要总结
The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •post-menopausal women : 50-90 years old
- •Group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months
- •Group 2 (controls) : no history of fragility fracture
排除标准
- •Implants that are contraindicated for the magnetic resonance (MR) examination.
- •Implants that might create a health risk or other problem during an MR exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant.
- •body mass index [BMI] >38 kg/m2, weight >140 kg
- •Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
- •Chronic kidney disease with DFG <30 ml/mn
结局指标
主要结局
Bone marrow fat content at lumbar spine
时间窗: 24 months
Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging
次要结局
- Bone mineral density at lumbar spine(24 months)
- Bone marrow fat content at total hip(24 months)
- Bone mineral density at total hip(24 months)
研究者
研究点 (1)
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