Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypoparathyroidism, Pseudo Hypoparathyroidism. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Incidence of primary hypoparathyroidism [Time frame: Day 1]
- Incidence of congenital hypoparathyroidism [Time frame: Day 1]
- Incidence of acquired hypoparathyroidism [Time frame: Day 1]
- Incidence of secondary hypoparathyroidism [Time frame: Day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Tunisia · 1 center
- Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques — Sfax
Identifiers
NCT: NCT06445036 · DAC-015-THYPARS