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Completed

NCT Number: NCT06449729

Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism

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

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea Giustina

Milan, 20132, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample and urine collection

Diagnostic Test

Blood sample and urine collection as per clinical practice

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: ENDORSE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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