Bone Fragility Evaluation in Obese Patients

NCT04174495 | Completed DMC

• 1 other identifier: 2019PI216
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1

  on axial section of the first lumbar vertebra, with a region of interest

  November 2019-September 2020

Secondary Outcomes (4)

• Vertebral fracture

  November 2019-September 2020

• DXA: T-score

  November 2019-September 2020

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

  November 2019-September 2020

• DXA: lean and fat mass

  November 2019-September 2020

Study Arms (1)

Obese patients followed at Nancy University Hospital

Diagnostic Test: DXA and CT-scan

Interventions

DXA and CT-scan DIAGNOSTIC_TEST

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

Obese patients followed at Nancy University Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \< 18 years
• Protected adults

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Centre Hospitalier de Toul Saint Charles: collaborator

Study Sites (1)

Nancy university hosiptal

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (20)

• Murray TE, Williams D, Lee MJ. Osteoporosis, obesity, and sarcopenia on abdominal CT: a review of epidemiology, diagnostic criteria, and management strategies for the reporting radiologist. Abdom Radiol (NY). 2017 Sep;42(9):2376-2386. doi: 10.1007/s00261-017-1124-5.

  PMID: 28386693 BACKGROUND

• Walsh JS, Vilaca T. Obesity, Type 2 Diabetes and Bone in Adults. Calcif Tissue Int. 2017 May;100(5):528-535. doi: 10.1007/s00223-016-0229-0. Epub 2017 Mar 9.

  PMID: 28280846 BACKGROUND

• Hammoud E, Toumi H, Jacob C, Pinti A, Lespessailles E, El Hage R. Does the Severity of Obesity Influence Bone Mineral Density Values in Premenopausal Women? J Clin Densitom. 2021 Apr-Jun;24(2):225-232. doi: 10.1016/j.jocd.2019.04.006. Epub 2019 Apr 26.

  PMID: 31109773 BACKGROUND

• Bauer JM, Cruz-Jentoft AJ, Fielding RA, Kanis JA, Reginster JY, Bruyere O, Cesari M, Chapurlat R, Al-Daghri N, Dennison E, Kaufman JM, Landi F, Laslop A, Locquet M, Maggi S, McCloskey E, Perna S, Rizzoli R, Rolland Y, Rondanelli M, Szulc P, Vellas B, Vlaskovska M, Cooper C. Is There Enough Evidence for Osteosarcopenic Obesity as a Distinct Entity? A Critical Literature Review. Calcif Tissue Int. 2019 Aug;105(2):109-124. doi: 10.1007/s00223-019-00561-w. Epub 2019 May 16.

  PMID: 31098729 BACKGROUND

• Jammah AA. Endocrine and metabolic complications after bariatric surgery. Saudi J Gastroenterol. 2015 Sep-Oct;21(5):269-77. doi: 10.4103/1319-3767.164183.

  PMID: 26458852 BACKGROUND

• Hong CS, Bergen MA, Watters TS. Transient osteoporosis of the hip after bariatric surgery. Arthroplast Today. 2018 Dec 7;5(1):32-37. doi: 10.1016/j.artd.2018.10.010. eCollection 2019 Mar.

  PMID: 31020018 BACKGROUND

• Lespessailles E, Hammoud E, Toumi H, Ibrahim-Nasser N. Consequences of bariatric surgery on outcomes in rheumatic diseases. Arthritis Res Ther. 2019 Mar 28;21(1):83. doi: 10.1186/s13075-019-1869-z.

  PMID: 30922375 BACKGROUND

• Santos D, Lopes T, Jesus P, Cruz S, Cordeiro A, Pereira S, Saboya C, Ramalho A. Bone Metabolism in Adolescents and Adults Undergoing Roux-En-Y Gastric Bypass: a Comparative Study. Obes Surg. 2019 Jul;29(7):2144-2150. doi: 10.1007/s11695-019-03797-5.

  PMID: 30820885 BACKGROUND

• Geoffroy M, Charlot-Lambrecht I, Chrusciel J, Gaubil-Kaladjian I, Diaz-Cives A, Eschard JP, Salmon JH. Impact of Bariatric Surgery on Bone Mineral Density: Observational Study of 110 Patients Followed up in a Specialized Center for the Treatment of Obesity in France. Obes Surg. 2019 Jun;29(6):1765-1772. doi: 10.1007/s11695-019-03719-5.

  PMID: 30734230 BACKGROUND

• Madsen LR, Espersen R, Ornstrup MJ, Jorgensen NR, Langdahl BL, Richelsen B. Bone Health in Patients with Type 2 Diabetes Treated by Roux-En-Y Gastric Bypass and the Role of Diabetes Remission. Obes Surg. 2019 Jun;29(6):1823-1831. doi: 10.1007/s11695-019-03753-3.

  PMID: 30719648 BACKGROUND

• Axelsson KF, Werling M, Eliasson B, Szabo E, Naslund I, Wedel H, Lundh D, Lorentzon M. Fracture Risk After Gastric Bypass Surgery: A Retrospective Cohort Study. J Bone Miner Res. 2018 Dec;33(12):2122-2131. doi: 10.1002/jbmr.3553. Epub 2018 Aug 13.

  PMID: 30011091 BACKGROUND

• Mesureur L, Arvanitakis M. Metabolic and nutritional complications of bariatric surgery : a review. Acta Gastroenterol Belg. 2017 Oct-Dec;80(4):515-525.

  PMID: 29560648 BACKGROUND

• Kalani A, Bami H, Tiboni M, Jaeschke R, Adachi JD, Lau AN. The effect of bariatric surgery on serum 25-OH vitamin D levels: a systematic review and meta-analysis. Obes Sci Pract. 2017 Jun 27;3(3):319-332. doi: 10.1002/osp4.113. eCollection 2017 Sep.

  PMID: 29071108 BACKGROUND

• Cook FJ, Khanna I, Giordano J, Matarese L, Hudson S. LONG-TERM BONE HEALTH AFTER ROUX-EN-Y GASTRIC BYPASS: A PILOT STUDY. Endocr Pract. 2017 Sep;23(9):1077-1084. doi: 10.4158/EP171823.OR. Epub 2017 Jul 6.

  PMID: 28683234 BACKGROUND

• Shanbhogue VV, Stoving RK, Frederiksen KH, Hanson S, Brixen K, Gram J, Jorgensen NR, Hansen S. Bone structural changes after gastric bypass surgery evaluated by HR-pQCT: a two-year longitudinal study. Eur J Endocrinol. 2017 Jun;176(6):685-693. doi: 10.1530/EJE-17-0014. Epub 2017 Mar 13.

  PMID: 28289103 BACKGROUND

• Yu EW, Lee MP, Landon JE, Lindeman KG, Kim SC. Fracture Risk After Bariatric Surgery: Roux-en-Y Gastric Bypass Versus Adjustable Gastric Banding. J Bone Miner Res. 2017 Jun;32(6):1229-1236. doi: 10.1002/jbmr.3101. Epub 2017 Mar 20.

  PMID: 28251687 BACKGROUND

• Pickhardt PJ, Lee LJ, del Rio AM, Lauder T, Bruce RJ, Summers RM, Pooler BD, Binkley N. Simultaneous screening for osteoporosis at CT colonography: bone mineral density assessment using MDCT attenuation techniques compared with the DXA reference standard. J Bone Miner Res. 2011 Sep;26(9):2194-203. doi: 10.1002/jbmr.428.

  PMID: 21590738 BACKGROUND

• Fauny M, Bauer E, Albuisson E, Perrier-Cornet J, Deibener J, Chabot F, Mandry D, Huttin O, Chary-Valckenaere I, Loeuille D. Vertebral fracture prevalence and measurement of the scanographic bone attenuation coefficient on CT-scan in patients with systemic sclerosis. Rheumatol Int. 2018 Oct;38(10):1901-1910. doi: 10.1007/s00296-018-4139-5. Epub 2018 Aug 21.

  PMID: 30132216 BACKGROUND

• Perrier-Cornet J, Omorou AY, Fauny M, Loeuille D, Chary-Valckenaere I. Opportunistic screening for osteoporosis using thoraco-abdomino-pelvic CT-scan assessing the vertebral density in rheumatoid arthritis patients. Osteoporos Int. 2019 Jun;30(6):1215-1222. doi: 10.1007/s00198-019-04931-w. Epub 2019 Mar 13.

  PMID: 30868182 BACKGROUND

• Fauny M, Albuisson E, Bauer E, Perrier-Cornet J, Chary-Valckenaere I, Loeuille D. Study of vertebral fracture and Scanographic Bone Attenuation Coefficient in rheumatoid arthritis and ankylosing spondylitis vs. controls. Sci Rep. 2019 Sep 16;9(1):13323. doi: 10.1038/s41598-019-49712-x.

  PMID: 31527613 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Absorptiometry, Photon; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Principal Investigator

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 22, 2019
• Study Start: February 23, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 23, 2021
• Last Updated: February 24, 2025

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)