Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-23 @ 6:03 AM
Study NCT ID:
NCT04174495
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2019-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Fragility Evaluation in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2019-11-16', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scanographic bone attenuation coefficient of the first lumbar vertebra SBAC-L1', 'timeFrame': 'November 2019-September 2020', 'description': 'on axial section of the first lumbar vertebra, with a region of interest'}], 'secondaryOutcomes': [{'measure': 'Vertebral fracture', 'timeFrame': 'November 2019-September 2020', 'description': 'According Genant classification, on sagittal section of spine'}, {'measure': 'DXA: T-score', 'timeFrame': 'November 2019-September 2020', 'description': 'in standard deviation, on spine / hip / femoral neck / wrist'}, {'measure': 'DXA: Bone mineral density BMD (spine, hip , femoral neck, wrist)', 'timeFrame': 'November 2019-September 2020', 'description': 'in g/cm²'}, {'measure': 'DXA: lean and fat mass', 'timeFrame': 'November 2019-September 2020', 'description': 'in % and repartition of each'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '28386693', 'type': 'BACKGROUND', 'citation': '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': '28280846', 'type': 'BACKGROUND', '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.'}, {'pmid': '31109773', 'type': 'BACKGROUND', '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. 2021 Apr-Jun;24(2):225-232. doi: 10.1016/j.jocd.2019.04.006. Epub 2019 Apr 26.'}, {'pmid': '31098729', 'type': 'BACKGROUND', 'citation': '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': '26458852', 'type': 'BACKGROUND', '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.'}, {'pmid': '31020018', 'type': 'BACKGROUND', '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.'}, {'pmid': '30922375', 'type': 'BACKGROUND', '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.'}, {'pmid': '30820885', 'type': 'BACKGROUND', '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.'}, {'pmid': '30734230', 'type': 'BACKGROUND', '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.'}, {'pmid': '30719648', 'type': 'BACKGROUND', 'citation': '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': '30011091', 'type': 'BACKGROUND', 'citation': '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': '29560648', 'type': 'BACKGROUND', 'citation': 'Mesureur L, Arvanitakis M. Metabolic and nutritional complications of bariatric surgery : a review. Acta Gastroenterol Belg. 2017 Oct-Dec;80(4):515-525.'}, {'pmid': '29071108', 'type': 'BACKGROUND', '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.'}, {'pmid': '28683234', 'type': 'BACKGROUND', '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.'}, {'pmid': '28289103', 'type': 'BACKGROUND', 'citation': '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': '28251687', 'type': 'BACKGROUND', '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.'}, {'pmid': '21590738', 'type': 'BACKGROUND', '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.'}, {'pmid': '30132216', 'type': 'BACKGROUND', '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.'}, {'pmid': '30868182', 'type': 'BACKGROUND', '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.'}, {'pmid': '31527613', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients followed at Nancy university hospital for a bariatric surgery\n* CT-scan and DXA performed before surgery, with maximum 1 year before the 2 exams\n\nExclusion Criteria:\n\n* \\< 18 years\n* Protected adults'}, 'identificationModule': {'nctId': 'NCT04174495', 'briefTitle': 'Bone Fragility Evaluation in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2019PI216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients followed at Nancy University Hospital', 'interventionNames': ['Diagnostic Test: DXA and CT-scan']}], 'interventions': [{'name': 'DXA and CT-scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'DXA and CT-scan are usually performed during the following of these patients before bariatric surgery', 'armGroupLabels': ['Obese patients followed at Nancy University Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Nancy university hosiptal', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier de Toul Saint Charles', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD; Principal Investigator', 'investigatorFullName': 'Marine FAUNY', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}