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

Osteodensitometry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965742
• Other study ID #: 2015-A00596-43
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2019
• Source: Diagnostic Medical Systems
• Contact: Laurent MAIMOUN, Phd.
• Phone: 0467338464
• Email: l-maimoun[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteodensitometry

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Montpellier	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
Diagnostic Medical Systems	University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lin concordance coefficient	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	Day 0