NCT06449729

Brief Summary

Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

June 4, 2024

Last Update Submit

June 4, 2024

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Interventions

Blood sample and urine collectionDIAGNOSTIC_TEST

Blood sample and urine collection as per clinical practice

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hypoparathyroidism being treated with calcitriol or alfacalcidiol.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea Giustina

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

Blood Specimen CollectionUrine Specimen Collection

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prorector and Head of Endocrinology

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

November 28, 2022

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

June 10, 2024

Record last verified: 2024-03

Locations

IT(1)