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

DACIMA

Status: Not yet enrolling

Conditions: Pseudo Hypoparathyroidism; Hypoparathyroidism

Study type: Observational

Funder types: Other

Identifiers

NCT06445036

DAC-015-THYPARS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.