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

NCT ID: NCT02609191

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-01

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.

Conditions

Osteodensitometry

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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"

Group Type: EXPERIMENTAL

Whole body exam using the "Discovery A"

Intervention Type: DEVICE

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

First whole body exam using the "Stratos DR"

Intervention Type: DEVICE

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

Second whole body exam using the "Stratos DR"

Intervention Type: DEVICE

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

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"

Group Type: EXPERIMENTAL

Whole body exam using the "Discovery A"

Intervention Type: DEVICE

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

First whole body exam using the "Stratos DR"

Intervention Type: DEVICE

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

Interventions

Whole body exam using the "Discovery A"

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

Intervention Type: DEVICE

First whole body exam using the "Stratos DR"

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DMS Apelem

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Boudousq, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 25450754 (View on PubMed)

Other Identifiers

2015-A00987-42

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/VB-01

Identifier Type: -

Identifier Source: org_study_id