HyperparathyroidismNCT06797934
Establishment of a Registry of Patients With Parathyroid Disease
An observational study of Hyperparathyroidism and Hypoparathyroidism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Establishment of a registry with which to census all patients under the care of the O.U. Endocrinology for parathyroid pathology in order to longitudinally evaluate biochemical, clinical, radiological, medico-nuclear and histological data in future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Hypoparathyroidism
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2022to 31 Dec 2039
- How long will I take part?
- 10 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: Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.
Who may be able to join
- Age ≥18 years
- Diagnosis of hyperparathyroidism or hypoparathyroidism based on biochemical parameters (calcemia, parathormone, phosphormia, creatinine, albumin, vitamin D25OH)
- 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
Establishment of a registry with which to census all patients under the care of the O.U. Endocrinology for parathyroid pathology in order to longitudinally evaluate biochemical, clinical, radiological, medico-nuclear and histological data in future studies.
Read the detailed description
Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.
- Conditions
- Hyperparathyroidism, Hypoparathyroidism
- Medical subject headings
- Hyperparathyroidism, Hypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Biochemical Monitoring in Patients with Parathyroid Pathology
This outcome measure will specifically assess and report biochemical parameters in patients with parathyroid pathology under the care of the O.U. Endocrinology. Key biochemical markers to be measured include:
Serum calcium levels (mmol/L) Serum phosphorus levels (mmol/L) Parathyroid hormone (PTH) levels (pg/mL) Vitamin D levels (ng/mL) Each parameter will be measured at baseline and at predefined intervals throughout the study. The collected data will be summarized as means ± standard deviations for continuous variables or as proportions for categorical data, where appropriate.
Measured: through study completion, an average of 15 years
Clinical Outcomes in Parathyroid Pathology: Symptom Severity, Biochemical Parameters, and Comorbidities
This outcome measure includes the assessment of multiple clinical parameters related to parathyroid pathology. These include:
Symptom Severity: Assessed using a standardized symptom severity scale, reported as a score.
Biochemical Parameters: Measurement of serum calcium levels (mg/dL) and parathyroid hormone (PTH) levels (pg/mL), summarized as means ± standard deviation.
Comorbidities: Documented as binary variables (present/absent) and reported as prevalence percentages.
Measured: through study completion, an average of 15 years
Radiological Assessments in Parathyroid Pathology: Imaging Findings and Anatomical Evaluation
This outcome measure involves the collection and evaluation of radiological data to assess the anatomical and functional status of the parathyroid glands and related structures. Specific assessments include:
Ultrasound Findings: Measurement of gland size (in centimeters) and structural abnormalities.
CT and MRI Results: Detection of anatomical changes or lesions, reported as present/absent and described qualitatively.
Bone Scans: Evaluation of bone metabolism abnormalities, summarized as binary outcomes (normal/abnormal).
Each imaging modality will be analyzed and reported independently, with results summarized based on specific Units of Measure, such as size (cm) or qualitative descriptors.
Measured: through study completion, an average of 15 years
Medico-Nuclear Outcomes: Parathyroid Imaging and Functional Assessment
This outcome measure focuses on data obtained from nuclear medicine imaging to evaluate parathyroid gland function. Specific assessments include:
Sestamibi Scan Results: Reported as qualitative findings (e.g., positive/negative for abnormal uptake) and quantified when applicable (e.g., uptake percentage).
Additional Imaging Modalities: Data from parathyroid-specific imaging (e.g., PET/CT or ultrasound) will include quantitative parameters such as gland size (cm³) and uptake intensity scores.
Each imaging modality will be analyzed and reported separately using appropriate Units of Measure. Aggregation methods will be clarified if data from multiple imaging types are combined to inform a single outcome metric.
Measured: through study completion, an average of 15 years
Histopathological Characteristics of Parathyroid Pathology
This outcome measure focuses on the collection and analysis of histological data from tissue samples. Specifically:
Biopsy Results: Histopathological features will be described qualitatively (e.g., presence of adenoma, hyperplasia) and quantitatively (e.g., cell counts, mitotic index per high-power field).
Post-Surgical Tissue Analysis: Includes structural characteristics such as tissue size (measured in millimeters), cellular composition, and presence of fibrosis or calcifications.
Each type of histopathological finding will be documented and analyzed independently, with appropriate Units of Measure used for quantitative assessments. Aggregated data will be summarized to provide insights into the cellular and structural characteristics of parathyroid pathology.
Measured: through study completion, an average of 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Jan 2022
- Primary completion30 Dec 2039 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies 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
- 1,200 participants (estimated)
- Target duration
- 10 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
- NCT06797934
- Sponsor's protocol ID
- PARAT
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Registry of Patients With Parathyroid Disease
- ClinicalTrials.gov ID
- NCT06797934
- Acronym / sponsor ID
- PARAT
- Conditions
- Hyperparathyroidism, Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Dec 2039 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 29 Jan 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.
Establishment of a registry with which to census all patients under the care of the O.U. Endocrinology for parathyroid pathology in order to longitudinally evaluate biochemical, clinical, radiological, medico-nuclear and histological data in future studies.
Detailed description
Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Diagnosis of hyperparathyroidism or hypoparathyroidism based on biochemical parameters (calcemia, parathormone, phosphormia, creatinine, albumin, vitamin D25OH)
- 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
Longitudinal Biochemical Monitoring in Patients with Parathyroid Pathology
Time frame: through study completion, an average of 15 years
This outcome measure will specifically assess and report biochemical parameters in patients with parathyroid pathology under the care of the O.U. Endocrinology. Key biochemical markers to be measured include: Serum calcium levels (mmol/L) Serum phosphorus levels (mmol/L) Parathyroid hormone (PTH) levels (pg/mL) Vitamin D levels (ng/mL) Each parameter will be measured at baseline and at predefined intervals throughout the study. The collected data will be summarized as means ± standard deviations for continuous variables or as proportions for categorical data, where appropriate.
Clinical Outcomes in Parathyroid Pathology: Symptom Severity, Biochemical Parameters, and Comorbidities
Time frame: through study completion, an average of 15 years
This outcome measure includes the assessment of multiple clinical parameters related to parathyroid pathology. These include: Symptom Severity: Assessed using a standardized symptom severity scale, reported as a score. Biochemical Parameters: Measurement of serum calcium levels (mg/dL) and parathyroid hormone (PTH) levels (pg/mL), summarized as means ± standard deviation. Comorbidities: Documented as binary variables (present/absent) and reported as prevalence percentages.
Radiological Assessments in Parathyroid Pathology: Imaging Findings and Anatomical Evaluation
Time frame: through study completion, an average of 15 years
This outcome measure involves the collection and evaluation of radiological data to assess the anatomical and functional status of the parathyroid glands and related structures. Specific assessments include: Ultrasound Findings: Measurement of gland size (in centimeters) and structural abnormalities. CT and MRI Results: Detection of anatomical changes or lesions, reported as present/absent and described qualitatively. Bone Scans: Evaluation of bone metabolism abnormalities, summarized as binary outcomes (normal/abnormal). Each imaging modality will be analyzed and reported independently, with results summarized based on specific Units of Measure, such as size (cm) or qualitative descriptors.
Medico-Nuclear Outcomes: Parathyroid Imaging and Functional Assessment
Time frame: through study completion, an average of 15 years
This outcome measure focuses on data obtained from nuclear medicine imaging to evaluate parathyroid gland function. Specific assessments include: Sestamibi Scan Results: Reported as qualitative findings (e.g., positive/negative for abnormal uptake) and quantified when applicable (e.g., uptake percentage). Additional Imaging Modalities: Data from parathyroid-specific imaging (e.g., PET/CT or ultrasound) will include quantitative parameters such as gland size (cm³) and uptake intensity scores. Each imaging modality will be analyzed and reported separately using appropriate Units of Measure. Aggregation methods will be clarified if data from multiple imaging types are combined to inform a single outcome metric.
Histopathological Characteristics of Parathyroid Pathology
Time frame: through study completion, an average of 15 years
This outcome measure focuses on the collection and analysis of histological data from tissue samples. Specifically: Biopsy Results: Histopathological features will be described qualitatively (e.g., presence of adenoma, hyperplasia) and quantitatively (e.g., cell counts, mitotic index per high-power field). Post-Surgical Tissue Analysis: Includes structural characteristics such as tissue size (measured in millimeters), cellular composition, and presence of fibrosis or calcifications. Each type of histopathological finding will be documented and analyzed independently, with appropriate Units of Measure used for quantitative assessments. Aggregated data will be summarized to provide insights into the cellular and structural characteristics of parathyroid pathology.
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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 Hyperparathyroidism and Hypoparathyroidism, 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 3 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 29 Jan 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?
Longitudinal Biochemical Monitoring in Patients with Parathyroid Pathology (time frame: through study completion, an average of 15 years). The study lists 5 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 29 Jan 2025.