Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dacima Consulting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Incidence of primary hypoparathyroidism
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Incidence of primary hypoparathyroidism
Time Frame: Day 1
Number of subjects with primary hypoparathyroidism at enrollment
Incidence of congenital hypoparathyroidism
Time Frame: Day 1
Number of subjects with congenital hypoparathyroidism at enrollment
Incidence of secondary hypoparathyroidism
Time Frame: Day 1
Number of subjects with secondary hypoparathyroidism at enrollment
Incidence of acquired hypoparathyroidism
Time Frame: Day 1
Number of subjects with acquired hypoparathyroidism at enrollment
Secondary Outcomes
No secondary outcomes reported