Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry

Not Applicable

Completed

• Conditions: Osteodensitometry
• Interventions: Device: Whole body exam using the "Discovery A"; Device: First whole body exam using the "Stratos DR"; Device: Second whole body exam using the "Stratos DR"

• Registration Number: NCT02609191
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2016-06
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population: last 20 patients	First whole body exam using the "Stratos DR"	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"
The study population: first 30 patients	First whole body exam using the "Stratos DR"	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"
The study population: first 30 patients	Whole body exam using the "Discovery A"	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"
The study population: first 30 patients	Second whole body exam using the "Stratos DR"	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"
The study population: last 20 patients	Whole body exam using the "Discovery A"	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"

Primary Outcome Measures

Name	Time	Method
Lin concordance coefficient for lean mass	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
Lin's concordance coefficient for Bone Mineral Density	Day 0	The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.
Lin's concordance coefficient for Bone Mineral Content	Day 0	The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France