NCT07480057 Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry
| NCT ID | NCT07480057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Chronic Liver Disease and ACLF |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-03-18 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. This 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. Pre-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.
Eligibility Criteria
Inclusion Criteria: \- All adult patients \>18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant Exclusion Criteria: 1. Patients not giving consent. 2. LT for ALF 3. Pediatric LT recipients 4. DDLT recipients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07480057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Liver Disease and ACLF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07480057 currently recruiting?
Yes, NCT07480057 is actively recruiting participants. Contact the research team at rahulshivhare93@gmail.com for enrollment information.
Where is the NCT07480057 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07480057 clinical trial?
NCT07480057 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 100 participants.