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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteodensitometry
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Lin concordance coefficient for lean mass
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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)
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.
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 Outcomes
- Lin's concordance coefficient for Bone Mineral Density(Day 0)
- Lin's concordance coefficient for Bone Mineral Content(Day 0)