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Completed

NCT Number: NCT04174495

Bone Fragility Evaluation 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.

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nancy university hosiptal

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DXA and CT-scan

Diagnostic Test

DXA and CT-scan are usually performed during the following of these patients before bariatric surgery

Primary outcomes

  1. 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

  1. Vertebral fracture

    Time frame: November 2019-September 2020

    According Genant classification, on sagittal section of spine

  2. DXA: T-score

    Time frame: November 2019-September 2020

    in standard deviation, on spine / hip / femoral neck / wrist

  3. DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)

    Time frame: November 2019-September 2020

    in g/cm²

  4. DXA: lean and fat mass

    Time frame: November 2019-September 2020

    in % and repartition of each

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Centre Hospitalier de Toul Saint Charles

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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