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

Not Applicable

• Conditions: Osteodensitometry

• 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

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