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

NCT07480057 | Recruiting

• 1 other identifier: ILBS-LT-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease and ACLF

Outcome Measures

Primary Outcomes (1)

• assessment of changes in bone mineral mass (BMM) after living donor liver transplant

  preoperative and at 3 months and 6 months post LDLT

Secondary Outcomes (5)

• 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

Study Arms (2)

CLD

All chronic liver disease undergoing living donor liver transplant.

Other: no intervention

ACLF

All acute on chronic liver failure patients undergoing living donor liver transplant.

Other: no intervention

Interventions

no intervention OTHER

No intervention as this is an observational study

ACLF; CLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- All adult patients \>18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant

You may not qualify if:

• Patients not giving consent.
• LT for ALF
• Pediatric LT recipients
• DDLT recipients

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Central Study Contacts

Rahul shivhare, MS

CONTACT

01146300000; rahulshivhare93@gmail.com

Viniyendra Pamecha, FRCS

CONTACT

01146300000; viniyendra@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IN (1)