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NCT Number: NCT07480057

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

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

Location status: Recruiting

Location contact

Rahul shivhare, MS

CONTACT

[email protected]

01143600000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No intervention as this is an observational study

Primary outcomes

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

    Time frame: preoperative and at 3 months and 6 months post LDLT

Secondary outcomes

  1. evaluate the association between the changes in BMM and gender

    Time frame: preoperative and at 3 months and 6 months post LDLT

  2. evaluate the association between the changes in BMM and age of patients

    Time frame: preoperative and at 3 months and 6 months post LDLT

  3. evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)

    Time frame: preoperative and at 3 months and 6 months post LDLT

  4. evaluate the association between the changes in BMM and etiology

    Time frame: preoperative and at 3 months and 6 months post LDLT

  5. evaluate the association between the changes in BMM with ICU stay and Hospital stay

    Time frame: preoperative and at 3 months and 6 months post LDLT

Study contacts

Contact information is provided by the study sponsor or research team.

Rahul shivhare, MS

CONTACT

[email protected]

01146300000

Viniyendra Pamecha, FRCS

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.