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Completed

NCT Number: NCT02609191

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

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.

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Key information

Conditions

Osteodensitometry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body exam using the "Discovery A"

Device

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

First whole body exam using the "Stratos DR"

Device

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

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.

Primary outcomes

  1. Lin concordance coefficient for fat mass

    Time frame: 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.

  2. Lin concordance coefficient for lean mass

    Time frame: 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.

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

    Time frame: 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)

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

    Time frame: 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 outcomes

  1. Lin's concordance coefficient for Bone Mineral Content

    Time frame: 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.

  2. Lin's concordance coefficient for Bone Mineral Density

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • DMS Apelem

Registry information

Official study 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

Acronym: STRATOS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.