Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lin concordance coefficient for lean mass
研究概览
简要总结
The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:
- Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
- And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.
详细描述
The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.
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
- 否
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.
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection or any kind of guardianship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The subject is suffering from a visually significant scoliosis
- •The patient is pregnant or breastfeeding
- •Patient weighing over 160 kg
- •Patient having undergone X-ray examination using a contrast medium such as barium in the 7 days preceding the visit
- •Patient who underwent an examination using γ rays in the 15 days preceding the visit
研究组 & 干预措施
The study population: first 30 patients
The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
Intervention: Second whole body exam using the "Stratos DR"
干预措施: Whole body exam using the "Discovery A" (Device)
The study population: first 30 patients
The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
Intervention: Second whole body exam using the "Stratos DR"
干预措施: First whole body exam using the "Stratos DR" (Device)
The study population: first 30 patients
The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
Intervention: Second whole body exam using the "Stratos DR"
干预措施: Second whole body exam using the "Stratos DR" (Device)
The study population: last 20 patients
The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
干预措施: Whole body exam using the "Discovery A" (Device)
The study population: last 20 patients
The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
干预措施: First whole body exam using the "Stratos DR" (Device)
结局指标
主要结局
Lin concordance coefficient for lean mass
时间窗: Day 0
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
RMS-%CV (root-mean-square coefficient of variation) for total fat mass
时间窗: Day 0
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
Lin concordance coefficient for fat mass
时间窗: Day 0
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
RMS-%CV (root-mean-square coefficient of variation) for total lean mass
时间窗: Day 0
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
次要结局
- Lin's concordance coefficient for Bone Mineral Density(Day 0)
- Lin's concordance coefficient for Bone Mineral Content(Day 0)