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Clinical Trials/NCT04174495
NCT04174495
Completed
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country1,500 target enrollmentFebruary 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Central Hospital, Nancy, France
Enrollment
1500
Locations
1
Primary Endpoint
scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2020
End Date
August 23, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Marine FAUNY

MD; Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)(November 2019-September 2020)
  • DXA: T-score(November 2019-September 2020)
  • Vertebral fracture(November 2019-September 2020)
  • DXA: lean and fat mass(November 2019-September 2020)

Study Sites (1)

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