Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition
NCT ID: NCT02965742
Last Updated: 2019-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-02-29
2020-01-31
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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The study population: first 25 patients
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"
Stratos
A machine made by DMS group.
"Hologic QDR 4500A"
A machine made by Hologic inc.
"Hologic HORIZON A"
A machine made by Hologic inc.
The study population: last 25 patients
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"
Stratos
A machine made by DMS group.
"Hologic QDR 4500A"
A machine made by Hologic inc.
"Hologic HORIZON A"
A machine made by Hologic inc.
Interventions
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Stratos
A machine made by DMS group.
"Hologic QDR 4500A"
A machine made by Hologic inc.
"Hologic HORIZON A"
A machine made by Hologic inc.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Diagnostic Medical Systems
INDUSTRY
Responsible Party
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Principal Investigators
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Denis MARIANO-GOULART, Phd.Medecine
Role: PRINCIPAL_INVESTIGATOR
Nuclear department
Locations
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Centre Hospitalier Universitaire de Montpellier
Montpellier, Hérault, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-A00596-43
Identifier Type: -
Identifier Source: org_study_id
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