Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Liver Disease and ACLF
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rahul Shivhare, MS; Phone Number: 01146300000; Email: rahulshivhare93@gmail.com
• Study Contact Backup: Name: Viniyendra Pamecha, FRCS; Phone Number: 01146300000; Email: viniyendra@gmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences
      • Contact: Rahul shivhare, MS; Phone Number: 01143600000; Email: rahulshivhare93@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

all CLD and ACLF patients irrespective of etiology undergoing living donor liver transplant

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CLD; All chronic liver disease undergoing living donor liver transplant.	Other: no intervention; No intervention as this is an observational study
ACLF; All acute on chronic liver failure patients undergoing living donor liver transplant.	Other: no intervention; No intervention as this is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
assessment of changes in bone mineral mass (BMM) after living donor liver transplant	preoperative and at 3 months and 6 months post LDLT

Secondary Outcome Measures

Outcome Measure	Time Frame
evaluate the association between the changes in BMM and gender	preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and age of patients	preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)	preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and etiology	preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM with ICU stay and Hospital stay	preoperative and at 3 months and 6 months post LDLT

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ILBS-LT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No