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NCT06445036 Clinical Trial

Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.

Hypoparathyroidism Clinical Trial

— THYPARS  

Official title:
Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06445036
Other study ID # DAC-015-THYPARS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date February 1, 2025

Study information
Verified date May 2024
Source Dacima Consulting
Contact Nabila Rekik Mejdoub, MD
Phone +216 98 609 300
Email nabila.rekik.mejdoub@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tunisia Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques Sfax

Sponsors (2)
Lead Sponsor Collaborator
Dacima Consulting Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of primary hypoparathyroidism Number of subjects with primary hypoparathyroidism at enrollment At inclusion
Primary Incidence of congenital hypoparathyroidism Number of subjects with congenital hypoparathyroidism at enrollment At inclusion
Primary Incidence of acquired hypoparathyroidism Number of subjects with acquired hypoparathyroidism at enrollment At inclusion
Primary Incidence of secondary hypoparathyroidism Number of subjects with secondary hypoparathyroidism at enrollment At inclusion
See also
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Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
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Recruiting NCT05556629 - A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
Terminated NCT00395538 - Effects of PTH Replacement on Bone in Hypoparathyroidism Phase 3
Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
Completed NCT00001304 - Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 Phase 2
Completed NCT04569604 - QoL and Cognitive Function in Patients With Hypoparathyroidism
Completed NCT06449729 - Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism
Completed NCT03747029 - Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Completed NCT05684029 - Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
Not yet recruiting NCT06419270 - Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Completed NCT00473265 - Bone Properties in Hypoparathyroidism: Effects of PTH Phase 2/Phase 3
Active, not recruiting NCT05328076 - Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
Completed NCT03150108 - Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects Phase 1
Completed NCT04059380 - Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1
Completed NCT00793689 - Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy N/A

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