Bone Fragility Evaluation in Obese Patients

Completed

• Conditions: Bariatric Surgery Candidate; Obesity
• Interventions: Diagnostic Test: DXA and CT-scan

• Registration Number: NCT04174495
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-16
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2020-02-23
• Status Verified: 2021-08
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-23
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients followed at Nancy University Hospital	DXA and CT-scan	-

Primary Outcome Measures

Name	Time	Method
scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1	November 2019-September 2020	on axial section of the first lumbar vertebra, with a region of interest

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nancy university hosiptal; 🇫🇷 Vandœuvre-lès-Nancy, France