Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Bone parameters
研究概览
简要总结
Background:
After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.
Aims:
To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.
Subjects:
250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.
Methods:
Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spinal Cord Injury
- •mobilized patients
- •written informed consent
排除标准
- •current fracture
- •limited mobility
- •contractures of the lower limbs
- •decubitus ulcer
- •pregnancy
结局指标
主要结局
Bone parameters
时间窗: just one timepoint
Measurement of the extremities with DEXA and pQCT
次要结局
- Fractures(just one timepoint (questionnaire))