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

March 13, 2019 updated by: Diagnostic Medical Systems

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Contact:
        • Principal Investigator:
          • Denis MARIANO-GOULART, Phd.Medecine
        • Sub-Investigator:
          • Aurélie BOURDON, Phd.Medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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"
Device: Stratos
A machine made by DMS group.
Device: "Hologic QDR 4500A"
A machine made by Hologic inc.
Device: "Hologic HORIZON A"
A machine made by Hologic inc.
Experimental: 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"
Device: Stratos
A machine made by DMS group.
Device: "Hologic QDR 4500A"
A machine made by Hologic inc.
Device: "Hologic HORIZON A"
A machine made by Hologic inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lin concordance coefficient
Time Frame: 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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diagnostic Medical Systems

Collaborators

University Hospital, Montpellier

Investigators

  • Principal Investigator: Denis MARIANO-GOULART, Phd.Medecine, Nuclear department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-A00596-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteodensitometry

Clinical Trials on Stratos

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe