Bone Fragility Evaluation in Obese Patients

January 24, 2020 updated by: Central Hospital, Nancy, France

Bone Fragility Evaluation by Dual X-Ray Absorptiometry (DXA) and CT-scan (Vertebral Fracture and Scanographic Bone Attenuation Coefficient of the First Lumbar Vertebra SBAC-L1) in Obese Patients

This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • Nancy university hosiptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obese patients followed before a bariatric surgery, at Nancy university hospital who performed a CT-scan and DXA, usually performed before surgery, with a delay which did not exceed 1 year before the 2 exams

Description

Inclusion Criteria:

  • patients followed at Nancy university hospital for a bariatric surgery
  • CT-scan and DXA performed before surgery, with maximum 1 year before the 2 exams

Exclusion Criteria:

  • < 18 years
  • Protected adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese patients followed at Nancy University Hospital
Diagnostic test: DXA and CT-scan
DXA and CT-scan are usually performed during the following of these patients before bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1
Time Frame: November 2019-September 2020
on axial section of the first lumbar vertebra, with a region of interest
November 2019-September 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertebral fracture
Time Frame: November 2019-September 2020
According Genant classification, on sagittal section of spine
November 2019-September 2020
DXA: T-score
Time Frame: November 2019-September 2020
in standard deviation, on spine / hip / femoral neck / wrist
November 2019-September 2020
DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)
Time Frame: November 2019-September 2020
in g/cm²
November 2019-September 2020
DXA: lean and fat mass
Time Frame: November 2019-September 2020
in % and reartition of each
November 2019-September 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2019PI216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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