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Clinical Trials/NCT04174495
NCT04174495CompletedNot 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 enrollmentStarted: February 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,500
Locations
1
Primary Endpoint
scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

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

Marine FAUNY

MD; Principal Investigator

Central Hospital, Nancy, France

Study Sites (1)

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