Establishment of a Registry of Patients with Parathyroid Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperparathyroidism; Hypoparathyroidism

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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Uberto Pagotto, MD; Phone Number: +390512144190; Email: uberto.pagotto@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Uberto Pagotto, MD
    • Contact: Uberto Pagotto, MD; Phone Number: +390512144190; Email: uberto.pagotto@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Age ≥18 years
• Diagnosis of hyperparathyroidism or hypoparathyroidism based on biochemical parameters (calcemia, parathormone, phosphormia, creatinine, albumin, vitamin D25OH)
• Obtaining informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	through study completion, an average of 15 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Uberto Pagotto, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): December 30, 2039
• Study Completion (Estimated): December 31, 2039

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Hyperparathyroidism; Hypoparathyroidism; Parathyroid Diseases
• Other Study ID Numbers: PARAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No