OsteoporosisNCT06838702
Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism
An observational study of Osteoporosis and Liver Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Liver Transplant
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2023to 11 Jan 2028
- How long will I take part?
- 5 Years
- 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: Patients undergoing liver transplantation and followed at the Endocrinology Operating Unit for bone mineral metabolism.
Who may be able to join
- Age >18 years
- Patients undergoing liver transplantation for any cause.
- Performance of bone densitometry
- Performance of examinations pertaining to mineral metabolism
- Obtaining informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Uberto Pagotto, MD, +390512144190, uberto.pagotto@unibo.it
Uberto Pagotto, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Osteoporosis, Liver Transplant
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: through study completion, an average of 4 years
Secondary outcomes (2)
Prevalence of Fractures in Patients Undergoing Liver Transplantation
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.
Measured: through study completion, an average of 4 years
Relationship Between Biochemical Parameters and Bone Mineral Density (BMD) Trends in Liver Transplant Patients
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.
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start11 Jan 2023
- Primary completion10 Jan 2028 (estimated)
- Study completion11 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uberto Pagotto, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838702
- Sponsor's protocol ID
- AEPOFE
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism
- ClinicalTrials.gov ID
- NCT06838702
- Acronym / sponsor ID
- AEPOFE
- Conditions
- Osteoporosis, Liver Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 10 Jan 2028 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 21 Feb 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation and followed at the Endocrinology Operating Unit for bone mineral metabolism.
Key inclusion criteria (5 listed)
- Age >18 years
- Patients undergoing liver transplantation for any cause.
- Performance of bone densitometry
- Performance of examinations pertaining to mineral metabolism
- Obtaining informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
2 secondary outcomes
Prevalence of Fractures in Patients Undergoing Liver Transplantation
Time frame: through study completion, an average of 4 years
Relationship Between Biochemical Parameters and Bone Mineral Density (BMD) Trends in Liver Transplant Patients
Time frame: through study completion, an average of 4 years
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 21 Feb 2025.
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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.
Uberto Pagotto, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Osteoporosis and Liver Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 5 inclusion and 1 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 21 Feb 2025. 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 Italy. 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 Uberto Pagotto, MD (+390512144190, uberto.pagotto@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mass in Liver Transplant Patients (time frame: through study completion, an average of 4 years). The study lists 3 primary outcomes in all. 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 21 Feb 2025.