Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06838702

Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism

Observational cohort study offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Uberto Pagotto, MD

CONTACT

[email protected]

+390512144190

Uberto Pagotto, MD

PRINCIPAL_INVESTIGATOR

About this study

The retrospective and prospective single-center observational cohort study will be offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment at UO Endocrinology of Policlinico S. Orsola-Malpighi.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • Patients undergoing liver transplantation for any cause.
  • Performance of bone densitometry
  • Performance of examinations pertaining to mineral metabolism
  • Obtaining informed consent

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Bone Mass in Liver Transplant Patients

    Time frame: through study completion, an average of 4 years

    Evaluation of bone mass in patients undergoing liver transplantation followed at the Endocrinology Operating Unit for Bone Mineral Metabolism, through the creation of a structured data collection in which to census all cases diagnosed and evaluated since 1/1/2009 at the U.O. Endocrinology of the S. Orsola-Malpighi Polyclinic. For the prospective phase, the expected duration of individual patient observation is 5 years

  2. Calcium Metabolism Indices in Liver Transplant Patients

    Time frame: through study completion, an average of 4 years

    Evaluation of laboratory values related to calcium metabolism in patients undergoing liver transplantation, specifically focusing on blood levels of calcium, phosphate, parathyroid hormone (PTH), and vitamin D. These parameters will be assessed using standard laboratory tests conducted at the Endocrinology Operating Unit for Bone Mineral Metabolism. Data will be collected through a structured registry that includes all cases diagnosed and evaluated since 1/1/2009 at the U.O. Endocrinology of the S. Orsola-Malpighi Polyclinic.

  3. Fracture Incidence in Liver Transplant Patients

    Time frame: through study completion, an average of 4 years

    Evaluation of fracture incidence in patients undergoing liver transplantation in patients undergoing liver transplantation followed at the Endocrinology Operating Unit for Bone Mineral Metabolism, through the creation of a structured data collection in which to census all cases diagnosed and evaluated since 1/1/2009 at the U.O. Endocrinology of the S. Orsola-Malpighi Polyclinic. For the prospective phase, the expected duration of individual patient observation is 5 years

Secondary outcomes

  1. Prevalence of Fractures in Patients Undergoing Liver Transplantation

    Time frame: through study completion, an average of 4 years

    This measure will assess the correlation between liver transplantation and the prevalence of fractures in patients followed at the Endocrinology Unit. Fractures will be identified through clinical records and radiological assessments. The prevalence will be reported as the percentage of patients with fractures (%) within the study population.

  2. Relationship Between Biochemical Parameters and Bone Mineral Density (BMD) Trends in Liver Transplant Patients

    Time frame: through study completion, an average of 4 years

    This measure will evaluate the correlation between specific biochemical parameters (e.g., calcium concentration in mg/dL, phosphate concentration in mg/dL, parathyroid hormone levels in pg/mL) and trends in bone mineral density (BMD) values in liver transplant patients. Bone Mineral Density (BMD) will be assessed using dual-energy X-ray absorptiometry (DEXA) scans, reported in g/cm². Biochemical parameters will be measured through blood tests, with each parameter reported in its respective unit of measure, with distinct units of measure and measurement tools explicitly identified.

Study contacts

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

Uberto Pagotto, MD

CONTACT

[email protected]

+390512144190

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

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.

Published trials that share one or more normalized conditions with this study.