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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02609191
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry STRATOS
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609191
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Vincent Boudousq, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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 ? rays in the 15 days preceding the visit



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteodensitometry

Intervention(s)

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

Device: Whole body exam using the "Discovery A"

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

Primary Outcome(s)

RMS-%CV (root-mean-square coefficient of variation) for total lean mass [Time Frame: Day 0]

Lin concordance coefficient for lean mass [Time Frame: Day 0]

Lin concordance coefficient for fat mass [Time Frame: Day 0]

RMS-%CV (root-mean-square coefficient of variation) for total fat mass [Time Frame: Day 0]

Secondary Outcome(s)

Lin's concordance coefficient for Bone Mineral Content [Time Frame: Day 0]

Lin's concordance coefficient for Bone Mineral Density [Time Frame: Day 0]

Secondary ID(s)

2015-A00987-42

LOCAL/2015/VB-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DMS Apelem