Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-29 @ 4:03 AM
Study NCT ID:
NCT03410459
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2018-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Adverse Effects After Bariatric Surgery on Bone Density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total hip T-Score measured with dual-energy x-ray absorptiometry', 'timeFrame': '5-7 years after bariatric surgery', 'description': 'measured score will be compared to reference score for this age'}], 'secondaryOutcomes': [{'measure': 'Total vertebral T-Score measured with dual-energy x-ray absorptiometry', 'timeFrame': '5-7 years after bariatric surgery', 'description': 'measured score will be compared to reference score for this age'}, {'measure': 'fracture risk assessed by FRAX score', 'timeFrame': '5-7 years after bariatric surgery', 'description': 'measured score will be compared to reference score for this age'}, {'measure': 'plasma concentration of C-terminal telopeptide (CTX)', 'timeFrame': '5-7 years after bariatric surgery', 'description': 'measured plasma concentration will be compared to reference for this age'}, {'measure': 'plasma concentration of vitamin D3', 'timeFrame': '5-7 years after bariatric surgery', 'description': 'measured plasma concentration will be compared to reference for this age'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.', 'detailedDescription': 'Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing,\n\nThe goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.\n\nExclusion Criteria:\n\n* LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)'}, 'identificationModule': {'nctId': 'NCT03410459', 'acronym': 'FUB-A', 'briefTitle': 'Long-term Adverse Effects After Bariatric Surgery on Bone Density', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)', 'orgStudyIdInfo': {'id': 'FUB Study Bone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gastric Bypass', 'description': 'Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density', 'interventionNames': ['Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleeve gastrectomy', 'description': 'Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density', 'interventionNames': ['Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)']}], 'interventions': [{'name': 'DEXA (= Dual-energy x-ray absorptiometry)', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of vertebral bone and hip bone mineral density', 'armGroupLabels': ['Gastric Bypass', 'Sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4016', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'St Claraspital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Bettina K Wölnerhanssen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research St. Claraspital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}