Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism

NCT06445036 | Not Yet Recruiting

• 1 other identifier: DAC-015-THYPARS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoparathyroidism; Pseudo Hypoparathyroidism

Keywords

Hypoparathyroidism; Pseudo Hypoparathyroidism; Clinical Registry; Endocrinology; Parathyroid gland

Outcome Measures

Primary Outcomes (4)

• Incidence of primary hypoparathyroidism

  Number of subjects with primary hypoparathyroidism at enrollment

  Day 1

• Incidence of congenital hypoparathyroidism

  Number of subjects with congenital hypoparathyroidism at enrollment

  Day 1

• Incidence of acquired hypoparathyroidism

  Number of subjects with acquired hypoparathyroidism at enrollment

  Day 1

• Incidence of secondary hypoparathyroidism

  Number of subjects with secondary hypoparathyroidism at enrollment

  Day 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dacima Consulting: lead
• Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques: collaborator

Study Sites (1)

Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Sfax, Tunisia, 3000, Tunisia

Location

Related Links

• Website of Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

MeSH Terms

Conditions

Hypoparathyroidism; Pseudohypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders

Study Officials

• Nabila Rekik Mejdoub, MD

  Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

  STUDY CHAIR

Central Study Contacts

Nabila Rekik Mejdoub, MD

CONTACT

+216 98 609 300; nabila.rekik.mejdoub@gmail.com

Rabie Razgallah, MD

CONTACT

+216 20 509 729; rabie.razgallah@evidentiq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: February 27, 2025
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

TU (1)