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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

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 1, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • 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.
  • 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.
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Osteodensitometry
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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"

    Interventions:
    • 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"
  • 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"

    Interventions:
    • Device: Whole body exam using the "Discovery A"
    • Device: First whole body exam using the "Stratos DR"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609191
Other Study ID Numbers  ICMJE LOCAL/2015/VB-01
2015-A00987-42 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE DMS Apelem
Investigators  ICMJE
Principal Investigator: Vincent Boudousq, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP