Survey on Epidemiology of Hypoparathyroidism in France (Epi-Hypo)

September 7, 2023 updated by: Jean-philippe Bertocchio, MD, PhD, European Georges Pompidou Hospital

Epi-Hypo: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Aix-en-Provence, France, 13100
        • Recruiting
        • Hôpital Privé de Provence
        • Contact:
          • Nicolas Dervaux, MD
      • Amiens, France, 80054
      • Auch, France
      • Aurillac, France
        • Recruiting
        • Henri Mondor Hospital
        • Contact:
      • Besançon, France
      • Bobigny, France, 93000
      • Bondy, France
        • Recruiting
        • Jean Verdier Hospital, AP-HP
        • Contact:
      • Bordeaux, France
        • Recruiting
        • University Hospital
        • Contact:
        • Sub-Investigator:
          • Renaud de La Faille, MD, PhD
      • Bourgoin-Jallieu, France
      • Brest, France
        • Recruiting
        • La Cavale Blanche Hospital
        • Contact:
        • Sub-Investigator:
          • Véronique Kerlan, MD
      • Caen, France
        • Recruiting
        • Côte de Nacre Hospital
        • Contact:
      • Créteil, France
        • Recruiting
        • Henri Mondor Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Céline Droumaguet, MD
      • Dax, France
        • Recruiting
        • Dax-Côte d'Argent Hospital
        • Contact:
      • Dijon, France
        • Recruiting
        • University Hospital
        • Contact:
        • Sub-Investigator:
          • Bruno Vergès, MD, PhD
      • Grenoble, France
      • La Roche-sur-Yon, France, 85925
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Kremlin-Bicêtre Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Peter Kamenicky, MD, PhD
      • Le Mans, France
        • Recruiting
        • Le Mans hospital
        • Contact:
      • Libourne, France
      • Lille, France
        • Recruiting
        • Claude Huriez Hospital
        • Contact:
      • Lyon, France
        • Recruiting
        • Edouard Herriot Hospital, HCL
        • Contact:
        • Sub-Investigator:
          • Justine Bacchetta, MD, PhD
      • Marseille, France
        • Recruiting
        • La Conception Hospital, AP-HM
        • Contact:
        • Sub-Investigator:
          • Mickaël Bobot, MD
        • Sub-Investigator:
          • Marion Pelletier, MD
      • Metz, France
      • Metz, France
      • Montpellier, France
        • Recruiting
        • Arnaud de villeneuve Hospital
        • Contact:
        • Sub-Investigator:
          • Isabelle Raingeard, MD
      • Mérignac, France
      • Nancy, France
        • Recruiting
        • Brabois Hospital
        • Contact:
      • Nantes, France
      • Nice, France, 06200
        • Recruiting
        • University Hospital
        • Contact:
          • Nicolas Chevalier, MD, PhD
        • Sub-Investigator:
          • Eléanore Fagot, MD
        • Sub-Investigator:
          • Sylvie Hieronimus, MD
        • Sub-Investigator:
          • Valentina Pautasso, MD
        • Sub-Investigator:
          • Sylvie Nicolau-Langlade, MD
        • Sub-Investigator:
          • Anne-Gaëlle Decoux-Poullot, MD
        • Sub-Investigator:
          • Stéphanie Telo, MD
        • Sub-Investigator:
          • Marie Hoflack, MD
      • Niort, France, 79000
      • Nîmes, France
        • Recruiting
        • Caremeau hospital
        • Sub-Investigator:
          • Olivier Gilly, MD
        • Contact:
        • Sub-Investigator:
          • Olivier Moranne, MD, PhD
      • Paris, France, 75908
        • Recruiting
        • European Georges Pompidou Hospital, APHP
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Philippe Bertocchio, MD, PhD
        • Sub-Investigator:
          • Pascal Houillier, MD, PhD
        • Sub-Investigator:
          • Eric Thervet, MD, PhD
        • Sub-Investigator:
          • Anne Blanchard, MD, PhD
        • Sub-Investigator:
          • Philippine Davis, MD
        • Sub-Investigator:
          • Gérard Maruani, MD
      • Paris, France
        • Recruiting
        • Clinic Paris Area
        • Contact:
        • Sub-Investigator:
          • Jean-Marie Garcin, MD
        • Sub-Investigator:
          • Pascale Presberg, MD
        • Sub-Investigator:
          • Bruno Donadille, MD
        • Sub-Investigator:
          • Sylvie Roux-Guinot, MD
        • Sub-Investigator:
          • Emmanuelle Lecornet-Sokol, MD
      • Paris, France
        • Recruiting
        • Cochin Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Lionel Groussin, MD, PhD
        • Sub-Investigator:
          • Léopoldine Bricaire, MD
      • Paris, France
        • Recruiting
        • Lariboisière Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Martine Cohen-Solal, MD, PhD
      • Paris, France
        • Recruiting
        • Necker Hospital, AP-HP
        • Contact:
        • Sub-Investigator:
          • Christophe Legendre, MD, PhD
      • Paris, France
        • Recruiting
        • Pitié-Salpêtrière Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Cécile Ghander, MD
        • Sub-Investigator:
          • Geoffroy Desbuissons, MD
        • Sub-Investigator:
          • Hassan Izzedine, MD, PhD
        • Sub-Investigator:
          • Christel Jublanc, MD
        • Sub-Investigator:
          • Isabelle Tostivint, MD
      • Paris, France
        • Recruiting
        • Tenon Hospital, APHP
        • Contact:
        • Sub-Investigator:
          • Emmanuel Letavernier, MD, PhD
      • Poitiers, France
        • Recruiting
        • Clinic Poitiers Area
        • Contact:
      • Quimper, France
      • Reims, France
        • Recruiting
        • Reims University Hospital
        • Contact:
        • Sub-Investigator:
          • Antoine Braconnier, MD, MSc
      • Rennes, France
        • Recruiting
        • Clinic Rennes Area
        • Contact:
      • Rouen, France
      • Saint-Junien, France, 87200
      • Saint-Ouen, France
      • Strasbourg, France
      • Toulon, France
        • Recruiting
        • Sainte Anne Hospital, HIA
        • Contact:
      • Toulouse, France
      • Tourcoing, France
      • Tours, France
        • Recruiting
        • Bretonneau Hospital
        • Contact:
        • Sub-Investigator:
          • Lise Crinière, MD
        • Sub-Investigator:
          • Elise Pinto Da Rocha, MD
      • Valenciennes, France
        • Recruiting
        • Valenciennes Hospital
        • Contact:
        • Sub-Investigator:
          • Marc Ulrich, MD
        • Sub-Investigator:
          • Aniela Stroea, MD
      • Villeneuve-Saint-Georges, France
    • La Réunion
      • Saint-Denis, La Réunion, France
        • Recruiting
        • Felix Guyon Hospital
        • Contact:
        • Sub-Investigator:
          • Arabelle Fioconni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients for whom hypoparathyroidism is diagnosed in France

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypoparathyroidism
No intervention.
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, about 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At inclusion (under treatment): through study completion, about 2 years
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
At inclusion (under treatment): through study completion, about 2 years
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
Through study completion, about 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Philippe Bertocchio, MD, PhD, European Georges Pompidou Hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

July 9, 2016

First Submitted That Met QC Criteria

July 17, 2016

First Posted (Estimated)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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