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

NCT06838702 | Recruiting

• 1 other identifier: AEPOFE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Liver Transplant

Outcome Measures

Primary Outcomes (3)

• Bone Mass in Liver Transplant Patients

  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

  through study completion, an average of 4 years

• Calcium Metabolism Indices in Liver Transplant Patients

  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.

  through study completion, an average of 4 years

• Fracture Incidence in Liver Transplant Patients

  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

  through study completion, an average of 4 years

Secondary Outcomes (2)

• Prevalence of Fractures in Patients Undergoing Liver Transplantation

  through study completion, an average of 4 years

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

  through study completion, an average of 4 years

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

Patients undergoing liver transplantation and followed at the Endocrinology Operating Unit for bone mineral metabolism.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Uberto Pagotto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uberto Pagotto, MD

CONTACT

+390512144190; uberto.pagotto@unibo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: February 21, 2025
• Study Start: January 11, 2023
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 11, 2028
• Last Updated: February 21, 2025

Record last verified: 2024-11

Locations

IT (1)