Bone Fragility Evaluation in Obese Patients

NCT ID: NCT04174495

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-23

Study Completion Date

2021-08-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Bariatric Surgery Candidate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Obese patients followed at Nancy University Hospital

DXA and CT-scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DXA and CT-scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier de Toul Saint Charles

UNKNOWN

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marine FAUNY

MD; Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nancy university hosiptal

Vandœuvre-lès-Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28386693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28280846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31109773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31098729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26458852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31020018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30922375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30820885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30734230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30719648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30011091 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29560648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29071108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28683234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28289103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28251687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21590738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30132216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30868182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31527613 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019PI216

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomechanics of Metastatic Defects in Bone
NCT02109952 ACTIVE_NOT_RECRUITING
Radiation Effects on Bone
NCT03134742 ENROLLING_BY_INVITATION