IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Location contact
Uberto Pagotto, MD
CONTACT
Uberto Pagotto, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06838702
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bologna, 40138, Italy
Location status: Recruiting
Uberto Pagotto, MD
CONTACT
Uberto Pagotto, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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
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.
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.
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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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.
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