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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Osteodensitometry

Treatments: Device: Second whole body exam using the "Stratos DR"; Device: Whole body exam using the "Discovery A"; Device: First whole body exam using the "Stratos DR"

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02609191

LOCAL/2015/VB-01

2015-A00987-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

The study population: first 30 patients

Experimental group

Description:

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"

Treatment:

Device: First whole body exam using the "Stratos DR"

Device: Whole body exam using the "Discovery A"

Device: Second whole body exam using the "Stratos DR"

The study population: last 20 patients

Experimental group

Description:

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"

Treatment:

Device: First whole body exam using the "Stratos DR"

Device: Whole body exam using the "Discovery A"