Bone Fragility Evaluation in Obese Patients

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04174495
• Other study ID #: 2019PI216
• Status: Not yet recruiting
• Start date: February 2020
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Central Hospital, Nancy, France
• Contact: Marine Fauny, MD
• Phone: +33383153203
• Email: m.fauny[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Nancy university hosiptal	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (20)

Axelsson KF, Werling M, Eliasson B, Szabo E, Näslund 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. — View Citation

Bauer JM, Cruz-Jentoft AJ, Fielding RA, Kanis JA, Reginster JY, Bruyère 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. Review. Erratum in: Calcif Tissue Int. 2019 Jul 23;:. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2019 Apr 26. pii: S1094-6950(19)30054-X. doi: 10.1016/j.jocd.2019.04.006. [Epub ahead of print] — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Madsen LR, Espersen R, Ornstrup MJ, Jørgensen 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. — View Citation

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

Murray TÉ, 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. Review. Erratum in: Abdom Radiol (NY). 2017 Aug 5;:. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shanbhogue VV, Støving RK, Frederiksen KH, Hanson S, Brixen K, Gram J, Jørgensen 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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vertebral fracture	According Genant classification, on sagittal section of spine	November 2019-September 2020
Secondary	DXA: T-score	in standard deviation, on spine / hip / femoral neck / wrist	November 2019-September 2020
Secondary	DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)	in g/cm²	November 2019-September 2020
Secondary	DXA: lean and fat mass	in % and reartition of each	November 2019-September 2020