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

NCT02609191 | Completed

• 2 other identifiers: LOCAL/2015/VB-012015-A00987-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteodensitometry

Outcome Measures

Primary Outcomes (4)

• Lin concordance coefficient for fat mass

  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.

  Day 0

• Lin concordance coefficient for lean mass

  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.

  Day 0

• RMS-%CV (root-mean-square coefficient of variation) for total fat mass

  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)

  Day 0

• RMS-%CV (root-mean-square coefficient of variation) for total lean mass

  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)

  Day 0

Secondary Outcomes (2)

• Lin's concordance coefficient for Bone Mineral Content

  Day 0

• Lin's concordance coefficient for Bone Mineral Density

  Day 0

Study Arms (2)

The study population: first 30 patients

EXPERIMENTAL

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"

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"

The study population: last 20 patients

EXPERIMENTAL

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"

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

Interventions

Whole body exam using the "Discovery A" DEVICE

Whole body exam using the "Discovery A" machine made by Hologic.

The study population: first 30 patients; The study population: last 20 patients

First whole body exam using the "Stratos DR" DEVICE

First whole body exam using the "Stratos DR" machine made by the DMS group.

The study population: first 30 patients; The study population: last 20 patients

Second whole body exam using the "Stratos DR" DEVICE

Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes.

The study population: first 30 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• DMS Apelem: collaborator

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French.

  PMID: 25450754 RESULT

Study Officials

• Vincent Boudousq, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 19, 2025

Record last verified: 2017-10

Locations

FR (1)