Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism

Completed

• Conditions: Hypoparathyroidism

• Registration Number: NCT06449729
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-28
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2024-03
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism	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

Trial Locations

Locations (1)

Andrea Giustina; 🇮🇹 Milan, Italy