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临床试验/NCT04301427
NCT04301427已完成不适用

Smallest Significant Value in Osteodensitomery in an Obese Population

CHU de Reims1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
120
试验地点
1
主要终点
osteodensitometry in obese population

研究概览

简要总结

The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI.

Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined.

Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.

详细描述

The aim of this study is to determined the smallest significant value in osteodensitometry in obese population.

There will be at least 120 patient included. The study population will be divided in 3 groups according to their BMI : the first group has a BMI between 30 and 35 kg/cm² ; the second group has a BMI between 35 et 40 kg/cm² ; and the third group has a BMI over 40 kg/cm².

Patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at CHU of Reims. Patients will be informed of the aim of the study by the prescriptor of the osteodensitometry.

The osteodensitometry will be executed by a nurse. Patients will have to complete a questionnaire about their medical history and their medications.

Bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. This exam lasts approximately 40 minutes.

研究设计

研究类型
Interventional
分配方式
Na
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

  • •Major patients
  • •Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density
  • •BMI > 30 kg/cm²
  • •Patient affiliated to a health insurance plan
  • •Patients who have signed informed consent

排除标准

  • •Minor patients
  • •Pregnant women
  • •Patients protected by the law

研究组 & 干预措施

Obese patient

Other

干预措施: Bone mineral density (Other)

结局指标

主要结局

osteodensitometry in obese population

时间窗: Day 1

smallest significant value in osteodensitometry in obese population

次要结局

  • osteodensitometry in obese population with BMI over 40 kg/cm²(Day 1)
  • osteodensitometry in obese population with BMI between 35 and 40 kg/cm²(Day 1)
  • osteodensitometry in obese population with BMI between 30 and 35 kg/cm²(Day 1)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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