Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism

NCT ID: NCT06445036

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-27

Study Completion Date

2025-07-27

Brief Summary

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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

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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.

Conditions

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Hypoparathyroidism Pseudo Hypoparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

UNKNOWN

Sponsor Role collaborator

Dacima Consulting

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabila Rekik Mejdoub, MD

Role: STUDY_CHAIR

Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Locations

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Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Sfax, Tunisia, Tunisia

Site Status

Countries

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Tunisia

Central Contacts

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Nabila Rekik Mejdoub, MD

Role: CONTACT

+216 98 609 300

Rabie Razgallah, MD

Role: CONTACT

+216 20 509 729

Facility Contacts

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Nabila Rekik Mejdoub, MD

Role: primary

+216 98 609 300

Rabie Razgallah, MD

Role: backup

+216 20 509 729

Related Links

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https://endocrino-tunisie.com/

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

Other Identifiers

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DAC-015-THYPARS

Identifier Type: -

Identifier Source: org_study_id

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