Clinical trial NCT02965742: Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition
Official title: Clinical Evaluation Of An X-Ray Bone Densitometer: Use Of DXA Technology For Precise Assessment Of Body Composition In Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteodensitometry
Keywords: DXA
DMS
DMS Imaging
STRATOS
Horizon A
QDR4500A
Lead sponsor: Diagnostic Medical Systems
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Montpellier
First posted: 2016-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lin concordance coefficient
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
state: Hérault
Study officials:
affiliation: Nuclear department
name: Denis MARIANO-GOULART, Phd.Medecine
role: PRINCIPAL_INVESTIGATOR
References: