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

Diagnostic Medical Systems

Status: Unknown

Conditions: Osteodensitometry

Treatments: Device: "Hologic HORIZON A"; Device: Stratos; Device: "Hologic QDR 4500A"

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02965742

2015-A00596-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

The study population: first 25 patients

Experimental group

Description:

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"

Treatment:

Device: "Hologic HORIZON A"

Device: Stratos

Device: "Hologic QDR 4500A"

The study population: last 25 patients

Experimental group

Description:

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"

Treatment:

Device: "Hologic HORIZON A"

Device: Stratos

Device: "Hologic QDR 4500A"