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NCT Number: NCT02838927

Survey on Epidemiology of Hypoparathyroidism in France

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.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Felix Guyon Hospital, Saint-Denis, La Réunion, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Assessment of the epidemiology of patients with hypoparathyroidism in France

    Time frame: Through study completion, about 2 years

    Data collected by questionnaire about etiology of hypoparathyroidism, filled by physicians from clinic folders

Secondary outcomes

  1. Assessment of the biology at inclusion will describe the evolution of the included population from diagnosis to now (inclusion)

    Time frame: 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

  2. Assessment of the management at inclusion will describe treatment and complications at inclusion

    Time frame: 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

  3. Assessment of the biology (calcemia, calciuria, parathormone, creatininemia, phosphatemia & magnesemia) at diagnosis and drug therapy at inclusion will describe population

    Time frame: 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

Other outcomes

  1. Assessment of the physician's management will help describing the habits of french physician who manage hypoparathyroidism in terms of follow-up

    Time frame: At inclusion

    Data on habits of included physicians about their management of patients with hypoparathyroidism: frequency of complications' follow-up (nephrocalcinosis, cataract, nephrolithiasis and other calcifications) in terms of radiology (CT-scan, echotomography, radiography) and biology (calcium in mM, phosphate in mM, parathormone in pg/ml, magnesium in mM, vitamin D in nmol/l and creatininemia in µM).

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe Bertocchio, MD, PhD

CONTACT

[email protected]

800-555-5555

Pascal Houillier, MD, PhD

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

European Georges Pompidou Hospital

Other

Collaborators

  • Oscar - Filière Santé Maladies Rares

Registry information

Official study title

Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France

Acronym: Epi-Hypo

Important dates

Study start
2016
Primary completion
2030
Study completion
2031
First posted
Jul 20, 2016
Registry last updated
Sep 24, 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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