NCT02609191|Completed
Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry
STRATOS
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STRATOS
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
50
1 country
1
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 1, 2017
Actual (reported)Study Completion
June 1, 2017
Actual (reported)The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2015
Actual (reported)November 20, 2015
Actual (reported)June 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 1, 2017
Actual (reported)June 1, 2017
Actual (reported)Lin concordance coefficient for fat mass
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.
Day 0
Lin concordance coefficient for lean mass
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.
Day 0
RMS-%CV (root-mean-square coefficient of variation) for total fat mass
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)
Day 0
RMS-%CV (root-mean-square coefficient of variation) for total lean mass
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)
Day 0
Lin's concordance coefficient for Bone Mineral Content
Day 0
Lin's concordance coefficient for Bone Mineral Density
Day 0
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"
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"
Whole body exam using the "Discovery A" machine made by Hologic.
First whole body exam using the "Stratos DR" machine made by the DMS group.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French.
Vincent Boudousq, MD
Centre Hospitalier Universitaire de Nīmes
50 participants (actual enrollment reported by the registry).
First Submitted
November 17, 2015
First Posted
November 20, 2015
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2017
Actual (reported)Study Completion
June 1, 2017
Actual (reported)Last Updated
November 19, 2025
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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