Tunisian Clinical Registry on Hypoparathyroidism and Pseu... | NCT06445036

Studies
Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism

NCT06445036

Sponsor

Dacima Consulting

Status

Not yet recruiting

Last Update Posted

Feb 21, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hypoparathyroidism
Pseudo Hypoparathyroidism

Interventions

Not provided

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2025Estimated

Primary Completion Date

Jul 27, 2025Estimated

Completion Date

Jul 27, 2025Estimated

First Submitted Date

May 31, 2024

First Submission Date that Met QC Criteria

May 31, 2024

First Posted Date

Jun 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2025

Last Update Posted Date

Feb 21, 2025Actual

Name	Class
Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Nabila Rekik Mejdoub, MD	Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques		Sfax	Tunisia	3000	Tunisia

References Module

Citations

Not provided

ID	Term
D007011	Hypoparathyroidism
D011547	Pseudohypoparathyroidism

ID	Term
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases