HypoparathyroidismTHYPARSNCT06445036
Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
An observational study of Hypoparathyroidism and Pseudo Hypoparathyroidism, run by Dacima Consulting at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoparathyroidism, Pseudo Hypoparathyroidism
- How many people
- 1,000 participants
- Where
- 1 siteTunisia
- Study dates
- 27 Feb 2025to 27 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism
Who may be able to join
- Hypoparathyroidism defined by low serum calcium < 2.2 mmol/l (< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
Sfax, Tunisia, 3000
Nabila Rekik Mejdoub, MD, +216 98 609 300, nabila.rekik.mejdoub@gmail.com
Rabie Razgallah, MD, +216 20 509 729, rabie.razgallah@evideniq.com
About this study
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.
Read the 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.
- Conditions
- Hypoparathyroidism, Pseudo Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Pseudo Hypoparathyroidism, Clinical Registry, Endocrinology, Parathyroid gland
- Medical subject headings
- Hypoparathyroidism, Pseudohypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of primary hypoparathyroidism
Number of subjects with primary hypoparathyroidism at enrollment
Measured: Day 1
Incidence of congenital hypoparathyroidism
Number of subjects with congenital hypoparathyroidism at enrollment
Measured: Day 1
Incidence of acquired hypoparathyroidism
Number of subjects with acquired hypoparathyroidism at enrollment
Measured: Day 1
Incidence of secondary hypoparathyroidism
Number of subjects with secondary hypoparathyroidism at enrollment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start27 Feb 2025 (estimated)
- Primary completion27 Jul 2025 (estimated)
- Study completion27 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
- Responsible party
- Sponsor
- Investigators
- Nabila Rekik Mejdoub, MD, Study chair, Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445036
- Sponsor's protocol ID
- DAC-015-THYPARS
- Acronym
- THYPARS
- Status last verified
- Feb 2025
- First submitted
- 31 May 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
- ClinicalTrials.gov ID
- NCT06445036
- Acronym / sponsor ID
- THYPARS / DAC-015-THYPARS
- Conditions
- Hypoparathyroidism, Pseudo Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Pseudo Hypoparathyroidism, Clinical Registry, Endocrinology, Parathyroid gland
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
- Study start
- 27 Feb 2025 (estimated)
- Primary completion
- 27 Jul 2025 (estimated)
- Study completion
- 27 Jul 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism
Key inclusion criteria (1 listed)
- Hypoparathyroidism defined by low serum calcium < 2.2 mmol/l (< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 acquired hypoparathyroidism
Time frame: Day 1
Number of subjects with acquired hypoparathyroidism at enrollment
Incidence of secondary hypoparathyroidism
Time frame: Day 1
Number of subjects with secondary hypoparathyroidism at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Website of Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies MétaboliquesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism
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The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabila Rekik Mejdoub, MD study chair
Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism and Pseudo Hypoparathyroidism, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila Rekik Mejdoub, MD (+216 98 609 300, nabila.rekik.mejdoub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary hypoparathyroidism (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.