Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:12 AM
Study NCT ID:
NCT07480057
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of changes in bone mineral mass (BMM) after living donor liver transplant', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}], 'secondaryOutcomes': [{'measure': 'evaluate the association between the changes in BMM and gender', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}, {'measure': 'evaluate the association between the changes in BMM and age of patients', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}, {'measure': 'evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}, {'measure': 'evaluate the association between the changes in BMM and etiology', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}, {'measure': 'evaluate the association between the changes in BMM with ICU stay and Hospital stay', 'timeFrame': 'preoperative and at 3 months and 6 months post LDLT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Liver Disease and ACLF']}, 'descriptionModule': {'briefSummary': 'Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Nutritional deficiencies are very common among CLD patients and due to this these patients suffer from low bone mineral density leading to osteoporosis and osteopenia. It has been observed that there is substantial reduction in bone density , especially within the first year of LT. The incidence of fractures among LT recipients has been reported to be around 3.5% with vertebral spine being the most common site. Multiple risk factors for osteoporosis after LT has been identified. Some of these include female sex, DM, sedentary lifestyle, pretransplant hypogonadism, Vit-D deficiency and pre-existing bone mineral abnormalities. Patients with CLD are also reported as having osteoblastic dysfunction by many factors, like unconjugated hyperbilirubinemia, decreased synthesis of collagen matrix, and decreased availability of insulin like growth factors. Post-transplant factors among LT recipients include: choice of immunosuppressive therapy like Glucocorticoid and CNIs therapy.\n\nThis Observational study aims to analyze the changes in bone mineral metabolism After Liver Transplantation by Bone Mineral Densitometry preoperatively and postoperatively. All eligible adult patients with Chronic Liver Disease undergoing Liver Transplant during the study period will be included in the study. These patients bone mineral density will be assessed using DEXA scan both preop and on Post op at 3 and 6 months. The association between the changes in BMM and various variables such as the sex of the patients, age of patients, etiology of CLD, presence of hepatocellular carcinoma (HCC), ICU stay, Hospital stay will be studied.\n\nPre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 6 months after the Liver Transplant and the bone mineral density will be compared between these patients along with other parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all CLD and ACLF patients irrespective of etiology undergoing living donor liver transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adult patients \\>18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant\n\nExclusion Criteria:\n\n1. Patients not giving consent.\n2. LT for ALF\n3. Pediatric LT recipients\n4. DDLT recipients'}, 'identificationModule': {'nctId': 'NCT07480057', 'briefTitle': 'Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry', 'orgStudyIdInfo': {'id': 'ILBS-LT-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CLD', 'description': 'All chronic liver disease undergoing living donor liver transplant.', 'interventionNames': ['Other: no intervention']}, {'label': 'ACLF', 'description': 'All acute on chronic liver failure patients undergoing living donor liver transplant.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'No intervention as this is an observational study', 'armGroupLabels': ['ACLF', 'CLD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rahul shivhare, MS', 'role': 'CONTACT', 'email': 'rahulshivhare93@gmail.com', 'phone': '01143600000'}], 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Rahul shivhare, MS', 'role': 'CONTACT', 'email': 'rahulshivhare93@gmail.com', 'phone': '01146300000'}, {'name': 'Viniyendra Pamecha, FRCS', 'role': 'CONTACT', 'email': 'viniyendra@gmail.com', 'phone': '01146300000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}