Chronic Liver Disease and ACLFNCT07480057
Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry
An observational study of Chronic Liver Disease and ACLF, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease and ACLF
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 18 Mar 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all CLD and ACLF patients irrespective of etiology undergoing living donor liver transplant
Who may be able to join
- All adult patients >18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant
Who cannot join
- Patients not giving consent.
- LT for ALF
- Pediatric LT recipients
- DDLT recipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Rahul shivhare, MS, 01143600000, rahulshivhare93@gmail.com
About this study
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
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention as this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| CLD | All chronic liver disease undergoing living donor liver transplant. Receives: Other: no intervention | |
| ACLF | All acute on chronic liver failure patients undergoing living donor liver transplant. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of changes in bone mineral mass (BMM) after living donor liver transplant
Measured: preoperative and at 3 months and 6 months post LDLT
Secondary outcomes (5)
evaluate the association between the changes in BMM and gender
Measured: preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and age of patients
Measured: preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)
Measured: preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and etiology
Measured: preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM with ICU stay and Hospital stay
Measured: preoperative and at 3 months and 6 months post LDLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start18 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and ACLFStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480057
- Sponsor's protocol ID
- ILBS-LT-01
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry
- ClinicalTrials.gov ID
- NCT07480057
- Acronym / sponsor ID
- ILBS-LT-01
- Conditions
- Chronic Liver Disease and ACLF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLD | – | Other: no interventionAll chronic liver disease undergoing living donor liver transplant. |
| ACLF | – | Other: no interventionAll acute on chronic liver failure patients undergoing living donor liver transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all CLD and ACLF patients irrespective of etiology undergoing living donor liver transplant
Key inclusion criteria (1 listed)
- All adult patients >18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant
Key exclusion criteria (4 listed)
- Patients not giving consent.
- LT for ALF
- Pediatric LT recipients
- DDLT recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention as this is an observational study | Other | ACLF, CLD |
Primary outcome
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
5 secondary outcomes
evaluate the association between the changes in BMM and gender
Time frame: preoperative and at 3 months and 6 months post LDLT
evaluate the association between the changes in BMM and age of patients
Time frame: preoperative and at 3 months and 6 months post LDLT
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
evaluate the association between the changes in BMM and etiology
Time frame: preoperative and at 3 months and 6 months post LDLT
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Liver Disease and ACLF
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
Not yet recruitingPhase 1/2
RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
RecruitingPhase 2
A-TANGO Phase 2 Study
Acute-On-Chronic Liver Failure, Alcoholic Hepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and ACLF, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul shivhare, MS (01146300000, rahulshivhare93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.