NCT02965742Unknown不适用
Clinical Evaluation Of An X-Ray Bone Densitometer: Use Of DXA Technology For Precise Assessment Of Body Composition In Humans
Diagnostic Medical Systems2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lin concordance coefficient
研究概览
简要总结
The main objectives of this study are:
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.
详细描述
The secondary objectives of this study are:
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is referred by a doctor for the performance of an osteodensitometry examination or sportsmen coming through a protocol where the nuclear medicine department is the investigator center
排除标准
- •The patient is pregnant or nursing
- •The patient is unable to sign or refuse to sign the informed consent
- •The patient has a coronary stent or metal sutures in the heart
- •The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
- •The patient has a pacemaker or defibrillator
- •Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide
- •The patient is using an insulin pump or with insulin-necked
- •The patient has undergone X-ray examination using a contrast medium such as barium in the previous seven days visit,
- •Patient who underwent an examination using x rays in the 15 days preceding the visit
- •Patient suffering from generalized edema
结局指标
主要结局
Lin concordance coefficient
时间窗: Day 0
In order to get a first idea of the adequacy of the two techniques measurements of the two bone densitometers, a calculation of intraclass correlation coefficients will be done. To supplement this data, a correlation study between the two techniques will be performed. For this we will use the Bland-Altman technique and a study of LIN concordance correlation coefficient
次要结局
未报告次要终点
研究者
研究点 (2)
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