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Bone Fragility Evaluation in Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174495
Recruitment Status : Unknown
Verified October 2019 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Obesity Bariatric Surgery Candidate Diagnostic Test: DXA and CT-scan

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 reartition of each



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174495


Contacts
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Contact: Marine Fauny, MD +33383153203 m.fauny@chru-nancy.fr

Locations
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France
Nancy university hosiptal
Vandœuvre-lès-Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Publications:

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04174495    
Other Study ID Numbers: 2019PI216
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No