Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism

Not yet recruiting

• Conditions: Hypoparathyroidism; Pseudo Hypoparathyroidism

• Registration Number: NCT06445036
• Lead Sponsor: Dacima Consulting

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Start: 2025-02-27
• Primary Completion: 2025-07-27
• Study Completion: 2025-07-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of primary hypoparathyroidism	Day 1	Number of subjects with primary hypoparathyroidism at enrollment
Incidence of congenital hypoparathyroidism	Day 1	Number of subjects with congenital hypoparathyroidism at enrollment
Incidence of secondary hypoparathyroidism	Day 1	Number of subjects with secondary hypoparathyroidism at enrollment
Incidence of acquired hypoparathyroidism	Day 1	Number of subjects with acquired hypoparathyroidism at enrollment

Trial Locations

Locations (1)

Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques; 🇹🇳 Sfax, Tunisia