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Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry (STRATOS)

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ClinicalTrials.gov Identifier: NCT02609191
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
DMS Apelem
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:

  • Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
  • And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.

Condition or disease Intervention/treatment Phase
Osteodensitometry Device: Whole body exam using the "Discovery A" Device: First whole body exam using the "Stratos DR" Device: Second whole body exam using the "Stratos DR" Not Applicable

Detailed Description:
The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers
Study Start Date : June 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
Experimental: The study population: first 30 patients

The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.

Intervention: Whole body exam using the "Discovery A"

Intervention: First whole body exam using the "Stratos DR"

Intervention: Second whole body exam using the "Stratos DR"

Device: Whole body exam using the "Discovery A"
Whole body exam using the "Discovery A" machine made by Hologic.

Device: First whole body exam using the "Stratos DR"
First whole body exam using the "Stratos DR" machine made by the DMS group.

Device: Second whole body exam using the "Stratos DR"
Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes.

Experimental: The study population: last 20 patients

The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.

Intervention: Whole body exam using the "Discovery A"

Intervention: First whole body exam using the "Stratos DR"

Device: Whole body exam using the "Discovery A"
Whole body exam using the "Discovery A" machine made by Hologic.

Device: First whole body exam using the "Stratos DR"
First whole body exam using the "Stratos DR" machine made by the DMS group.




Primary Outcome Measures :
  1. Lin concordance coefficient for fat mass [ Time Frame: Day 0 ]
    The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.

  2. Lin concordance coefficient for lean mass [ Time Frame: Day 0 ]
    The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.

  3. RMS-%CV (root-mean-square coefficient of variation) for total fat mass [ Time Frame: Day 0 ]
    Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)

  4. RMS-%CV (root-mean-square coefficient of variation) for total lean mass [ Time Frame: Day 0 ]
    Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)


Secondary Outcome Measures :
  1. Lin's concordance coefficient for Bone Mineral Content [ Time Frame: Day 0 ]
    The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.

  2. Lin's concordance coefficient for Bone Mineral Density [ Time Frame: Day 0 ]
    The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection or any kind of guardianship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The subject is suffering from a visually significant scoliosis
  • The patient is pregnant or breastfeeding
  • Patient weighing over 160 kg
  • Patient having undergone X-ray examination using a contrast medium such as barium in the 7 days preceding the visit
  • Patient who underwent an examination using γ rays in the 15 days preceding the visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609191


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
DMS Apelem
Investigators
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Principal Investigator: Vincent Boudousq, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02609191    
Other Study ID Numbers: LOCAL/2015/VB-01
2015-A00987-42 ( Other Identifier: RCB number )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017