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Clinical Trials/NCT06449729
NCT06449729CompletedNot Applicable

Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism on Conventional Treatment: a Cross-sectional Study

IRCCS San Raffaele1 site in 1 country46 target enrollmentStarted: November 28, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Giustina

Prorector and Head of Endocrinology

IRCCS San Raffaele

Study Sites (1)

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