Survey on Epidemiology of Hypoparathyroidism in France

Recruiting

• Conditions: Hypoparathyroidism

• Registration Number: NCT02838927
• Lead Sponsor: European Georges Pompidou Hospital

Brief Summary

Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none exists specifically for France. Hypoparathyroidism could led to complications. Here, the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

Detailed Description

Very few data has been published on the epidemiology of hypoparathyroidism worldwide. None exists specifically in France. Hypoparathyroidism could led to complications: e.g. symptomatic hypocalcemia, calcifications (brain, eye and other soft tissues), nephrolithiasis/nephrocalcinosis, renal insufficiency. Here,the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-09
• Study First Submitted QC: 2016-07-17
• Study First Posted: 2016-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2030-09
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• patient fro whom chronic hypoparathyroidism is diagnosed
• patient living in France

Exclusion Criteria

• patient who does not want his data to be collected in this registry
• pseudo-hypoparathyroidism
• acute hypoparathyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the epidemiology of patients with hypoparathyroidism in France	Through study completion, about 2 years	Data collected by questionnaire about etiology of hypoparathyroidism, filled by physicians from clinic folders

Secondary Outcome Measures

Name	Time	Method
Assessment of the biology (calcemia, calciuria, parathormone, creatininemia, phosphatemia & magnesemia) at diagnosis and drug therapy at inclusion will describe population	Through study completion, about 2 years	Number of patients with at least one anomaly at biology (calcemia in mM, calciuria in mmol/j, parathormone in pg/ml, creatininemia in µM, phosphatemia in mM, vitamin D in nmol/l \& magnesemia in mM) at diagnosis
Assessment of the biology at inclusion will describe the evolution of the included population from diagnosis to now (inclusion)	At inclusion (under treatment): through study completion, about 2 years	Number of patients with at least one anomaly at biology (calcemia in mM, calciuria in mmol/j, parathormone in pg/ml, creatininemia in µM, phosphatemia in mM, vitamin D in nmol/l \& magnesemia in mM) at inclusion
Assessment of the management at inclusion will describe treatment and complications at inclusion	At inclusion (under treatment): through study completion, about 2 years	Number of patients with clinical outcomes (complications such as cataract, nephrolithiasis, nephrocalcinosis, and others) and their management at inclusion

Trial Locations

Locations (54)

Blanquefort; 🇫🇷 Blanquefort, France

Saint-Louis Hospital, AP-HP; 🇫🇷 Paris, France

Passy Hospital; 🇫🇷 Passy, France

Saint Florent Le Vieil; 🇫🇷 Saint Florent Le Vieil, France

Felix Guyon Hospital; 🇫🇷 Saint-Denis, La Réunion, France

Hôpital Privé de Provence; 🇫🇷 Aix-en-Provence, France

Amiens University Hospital; 🇫🇷 Amiens, France

Clinic Auch Area; 🇫🇷 Auch, France

Henri Mondor Hospital; 🇫🇷 Aurillac, France

Jean Minjoz Hospital; 🇫🇷 Besançon, France

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