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

Osteodensitometry Clinical Trial

— STRATOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609191
• Other study ID #: LOCAL/2015/VB-01
• Secondary ID: 2015-A00987-42
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: October 31, 2017
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? rays in the 15 days preceding the visit

Related Conditions & MeSH terms

• Osteodensitometry

Intervention

Device:
• Whole body exam using the "Discovery A"
Whole body exam using the "Discovery A" machine made by Hologic.
• First whole body exam using the "Stratos DR"
First whole body exam using the "Stratos DR" machine made by the DMS group.
• Second whole body exam using the "Stratos DR"
Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	DMS Apelem

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Lin's concordance coefficient for Bone Mineral Content	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.	Day 0
Secondary	Lin's concordance coefficient for Bone Mineral Density	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.	Day 0