Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism (THYPARS)

February 20, 2025 updated by: Dacima Consulting
Observational, multicenter, national, cross-sectional study aiming to describe the epidemiological clinical, biological and therapeutic profile of patients suffering from defect in secretion (hypoparathyroidism) or action (pseudo-hypoparathyroidism) of parathyroid hormone.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Endocrinologists from both sectors (public and private) are participating in the study. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism

Description

Inclusion Criteria:

  • Hypoparathyroidism defined by low serum calcium < 2.2 mmol/l (< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine

Exclusion Criteria:

  • Cervical surgery < 6 months.
  • Transient (neonatal, etc.) or functional (dysmagnesemia, etc.) hypoparathyroidism.
  • Other causes of hypocalcemia: vitamin D deficiency, chronic renal failure, etc.
  • Familial hypocalcemia hypercalciuria.
  • Pseudo-pseudo-hypoparathyroidism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of primary hypoparathyroidism
Time Frame: Day 1
Number of subjects with primary hypoparathyroidism at enrollment
Day 1
Incidence of congenital hypoparathyroidism
Time Frame: Day 1
Number of subjects with congenital hypoparathyroidism at enrollment
Day 1
Incidence of acquired hypoparathyroidism
Time Frame: Day 1
Number of subjects with acquired hypoparathyroidism at enrollment
Day 1
Incidence of secondary hypoparathyroidism
Time Frame: Day 1
Number of subjects with secondary hypoparathyroidism at enrollment
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dacima Consulting

Collaborators

Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Investigators

  • Study Chair: Nabila Rekik Mejdoub, MD, Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 27, 2025

Primary Completion (Estimated)

July 27, 2025

Study Completion (Estimated)

July 27, 2025

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-015-THYPARS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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