HypoparathyroidismENDORSENCT06449729
Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism
An observational study of Hypoparathyroidism, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Blood sample and urine collection
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2022to 28 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with hypoparathyroidism being treated with calcitriol or alfacalcidiol.
Who may be able to join
- age ≥ 18 years
- diagnosis of chronic (≥ 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient PTH concentration in relation to the presence of hypocalcemia
- patients being treated with calcitriol or alfacalcidiol
- patients able to sign the written informed consent
Who cannot join
- pregnancy
- severe renal failure requiring dialysis treatment
- macroproteinuria
- use of antihypertensive drugs such as thiazides, ACE inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs
- pazients affected by diabetes mellitus- insulin-treated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism on Conventional Treatment: a Cross-sectional Study
Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)
- Conditions
- Hypoparathyroidism
- Being tested
- Blood sample and urine collection
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and urine collectionDiagnostic test
Blood sample and urine collection as per clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism
Evaluation of the prevalence of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism (hypoPTH) in conventional treatment with calcium and vitamin D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start28 Nov 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Giustina, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449729
- Sponsor's protocol ID
- BP 11006333
- Acronym
- ENDORSE
- Status last verified
- Mar 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism on Conventional Treatment: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06449729
- Acronym / sponsor ID
- ENDORSE / BP 11006333
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 10 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.
Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with hypoparathyroidism being treated with calcitriol or alfacalcidiol.
Key inclusion criteria (4 listed)
- age ≥ 18 years
- diagnosis of chronic (≥ 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient PTH concentration in relation to the presence of hypocalcemia
- patients being treated with calcitriol or alfacalcidiol
- patients able to sign the written informed consent
Key exclusion criteria (5 listed)
- pregnancy
- severe renal failure requiring dialysis treatment
- macroproteinuria
- use of antihypertensive drugs such as thiazides, ACE inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs
- pazients affected by diabetes mellitus- insulin-treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample and urine collectionBlood sample and urine collection as per clinical practice | Diagnostic test | – |
Primary outcome
The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism
Time frame: 12 months
Evaluation of the prevalence of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism (hypoPTH) in conventional treatment with calcium and vitamin D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Related trials for Hypoparathyroidism
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
RecruitingPhase 3
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
Hypoparathyroidism, Endocrine System Diseases
RecruitingPhase 3
Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism
Hypoparathyroidism, Chronic Hypoparathyroidism
RecruitingPhase 3
A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
Hypoparathyroidism
RecruitingObservational study
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
Pregnant Individuals, Aneuploidy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by IRCCS San Raffaele at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 10 Jun 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism (time frame: 12 months). 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 10 Jun 2024.