Clinical trial NCT02609191: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteodensitometry
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: DMS Apelem
First posted: 2015-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lin concordance coefficient for fat mass
timeFrame: Day 0
measure: Lin concordance coefficient for lean mass
timeFrame: Day 0
measure: RMS-%CV (root-mean-square coefficient of variation) for total fat mass
timeFrame: Day 0
measure: RMS-%CV (root-mean-square coefficient of variation) for total lean mass
timeFrame: Day 0
Secondary outcomes:
measure: Lin's concordance coefficient for Bone Mineral Content
timeFrame: Day 0
measure: Lin's concordance coefficient for Bone Mineral Density
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Boudousq, MD
role: PRINCIPAL_INVESTIGATOR
References: