Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition

Not Applicable

• Conditions: Osteodensitometry
• Interventions: Device: Stratos; Device: "Hologic QDR 4500A"; Device: "Hologic HORIZON A"

• Registration Number: NCT02965742
• Lead Sponsor: Diagnostic Medical Systems

Brief Summary

The main objectives of this study are:

* to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.

* to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.

Detailed Description

The secondary objectives of this study are:

* the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,

* the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,

* Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,

* Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-07
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 or sportsmen coming through a protocol where the nuclear medicine department is the investigator center

Exclusion Criteria

• The patient is pregnant or nursing
• The patient is unable to sign or refuse to sign the informed consent
• The patient has a coronary stent or metal sutures in the heart
• The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
• The patient has a pacemaker or defibrillator
• Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide
• The patient is using an insulin pump or with insulin-necked
• The patient has undergone X-ray examination using a contrast medium such as barium in the previous seven days visit,
• Patient who underwent an examination using x rays in the 15 days preceding the visit
• Patient suffering from generalized edema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population: last 25 patients	Stratos	The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"
The study population: first 25 patients	Stratos	The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"
The study population: first 25 patients	"Hologic HORIZON A"	The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"
The study population: first 25 patients	"Hologic QDR 4500A"	The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"
The study population: last 25 patients	"Hologic QDR 4500A"	The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"
The study population: last 25 patients	"Hologic HORIZON A"	The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"

Primary Outcome Measures

Name	Time	Method
Lin concordance coefficient	Day 0	In order to get a first idea of the adequacy of the two techniques measurements of the two bone densitometers, a calculation of intraclass correlation coefficients will be done. To supplement this data, a correlation study between the two techniques will be performed. For this we will use the Bland-Altman technique and a study of LIN concordance correlation coefficient

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, Hérault, France