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

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ClinicalTrials.gov Identifier: NCT02838927
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jean-philippe Bertocchio, 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.

Condition or disease Intervention/treatment
Hypoparathyroidism Other: No intervention

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
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hypoparathyroidism
No intervention.
Other: No intervention
No intervention




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients for whom hypoparathyroidism is diagnosed in France
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838927


Contacts
Contact: Jean-Philippe Bertocchio, MD, PhD (+33)156095625 jean-philippe.bertocchio@aphp.fr
Contact: Pascal Houillier, MD, PhD (+33)156095625 pascal.houillier@aphp.fr

Locations
France
Felix Guyon Hospital Recruiting
Saint-Denis, La Réunion, France
Contact: Xavier Debussche, MD    33262905610    xavier.debussche@chu-reunion.fr   
Sub-Investigator: Arabelle Fioconni, MD         
Clinic Auch Area Recruiting
Auch, France
Contact: Stéphane Castillo-Ros, MD    33562051340    stephane.castillo-ros@wanadoo.fr   
Henri Mondor Hospital Recruiting
Aurillac, France
Contact: Emmanuelle Dubosclard-Laguerre, MD    33471465658    e.dubosclard@ch-aurillac.fr   
Jean Minjoz Hospital Recruiting
Besançon, France
Contact: Sophie Borot, MD    33381668166    sophie.borot@univ-fcomte.fr   
Jean Verdier Hospital, AP-HP Recruiting
Bondy, France
Contact: Paul Elie Valensi, MD, PhD    331 48 95 51 51    paul.valensi@aphp.fr   
Haut-Levêque Hospital Recruiting
Bordeaux, France
Contact: Antoine Tabarin, MD, PhD    335 24 54 90 08    antoine.tabarin@chu-bordeaux.fr   
Bourgoin Jallieu Hospital Recruiting
Bourgoin-Jallieu, France
Contact: Louis De Laforcade, MD       ldelaforcade@gmail.com   
La Cavale Blanche Hospital Recruiting
Brest, France
Contact: Morgane Gosselin, MD    332 98 34 70 74    morgane.gosselin@gmail.com   
Côte de Nacre Hospital Recruiting
Caen, France
Contact: Yves Reznik, MD, PhD    33231064575    reznik-y@chu-caen.fr   
Henri Mondor Hospital, APHP Recruiting
Créteil, France
Contact: Thomas Stehle, MD    33149812457    thomas.stehle@aphp.Fr   
Sub-Investigator: Céline Droumaguet, MD         
Dax-Côte d'Argent Hospital Recruiting
Dax, France
Contact: Emmanuelle Bourrinet, MD    33558914848    bourrinete@ch-dax.fr   
University Hospital Recruiting
Dijon, France
Contact: Sylvie Picard, MD    33380702090    doc.sylvie.picard.md@orange.fr   
Sub-Investigator: Bruno Vergès, MD, PhD         
Grenoble Alpes Hospital Recruiting
Grenoble, France
Contact: Olivier Chabre, MD, PhD    33476765509    olivierchabre@chu-grenoble.fr   
Kremlin-Bicêtre Hospital, APHP Recruiting
Le Kremlin-Bicêtre, France
Contact: Agnès Linglart, MD, PhD    33145217846    agnes.linglart@aphp.fr   
Contact: Alessia Usardi    33145217836    alessia.usardi@aphp.fr   
Sub-Investigator: Peter Kamenicky, MD, PhD         
Le Mans Hospital Recruiting
Le Mans, France
Contact: Anne Dorange, MD    33243479933    anne.recton@neuf.fr   
Libourne Hospital Recruiting
Libourne, France
Contact: Adrien Keller, MD    33557553462    adrien.keller@ch-libourne.fr   
Claude Huriez Hospital Recruiting
Lille, France
Contact: Marie-Christine Vantyghem, MD, PhD    33320445962    mc-vantyghem@chru-lille.fr   
Edouard Herriot Hospital, HCL Recruiting
Lyon, France
Contact: Sandrine Lemoine, MD, PhD    33437538062    sandrine.lemoine01@chu-lyon.fr   
Sub-Investigator: Justine Bacchetta, MD, PhD         
La Conception Hospital, AP-HM Recruiting
Marseille, France
Contact: Thierry Brue, MD, PhD       Thierry.BRUE@ap-hm.fr   
Clinic Metz Area Recruiting
Metz, France
Contact: Valérie Aubert, MD    33387358132    dr.valerie.aubert@orange.fr   
Mercy Hospital Recruiting
Metz, France
Contact: Benjmain Savenkoff, MD    33387345100    benjamin.savenkoff@gmail.com   
Arnaud de Villeneuve Hospital Recruiting
Montpellier, France
Contact: Cyril Amouroux, MD    33467336733    cyril-amouroux@chu-montpellier.fr   
Clinic area Recruiting
Mérignac, France
Contact: Anne Nnavaranne-Roumec, MD       docteur.navarranne-roumec@orange.fr   
Brabois Hospital Recruiting
Nancy, France
Contact: Marc Klein, MD, PhD    33383153030    m.klein@chru-nancy.fr   
University Hospital Recruiting
Nantes, France
Contact: Lucile Figueres, MD, PhD    33240087453    lucile.figueres@chu-nantes.fr   
Caremeau Hospital Recruiting
Nîmes, France
Contact: Sophie Renaud, MD, PhD    33466686868    sophie.renaud@chu-nimes.fr   
Sub-Investigator: Olivier Moranne, MD, PhD         
European Georges Pompidou Hospital, APHP Recruiting
Paris, France, 75908
Contact: Jean-Philippe Bertocchio, MD, PhD    (+33)156095625    jean-philippe.bertocchio@aphp.fr   
Contact: Pascal Houillier, MD, PhD    (+33)156095625    pascal.houillier@aphp.fr   
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         
Clinic Paris Area Recruiting
Paris, France
Contact: Aurélie Rousseau, MD    33177456764    aurelie.rousseau15@gmail.com   
Sub-Investigator: Jean-Marie Garcin, MD         
Sub-Investigator: Pascale Presberg, MD         
Sub-Investigator: Bruno Donadille, MD         
Cochin Hospital, APHP Recruiting
Paris, France
Contact: Jérôme Bertherat, MD, PhD    33158411919    jerome.bertherat@aphp.fr   
Sub-Investigator: Lionel Groussin, MD, PhD         
Sub-Investigator: Léopoldine Bricaire, MD         
Lariboisière Hospital, APHP Recruiting
Paris, France
Contact: Jean-Pierre Riveline, MD    33149959072    jeanpierre.riveline@aphp.fr   
Sub-Investigator: Martine Cohen-Solal, MD, PhD         
Necker Hospital, AP-HP Recruiting
Paris, France
Contact: Bertrannd Knebelmannn, MD, PhD    33 1 44 49 54 58    bertrand.knebelmann@aphp.fr   
Sub-Investigator: Christophe Legendre, MD, PhD         
Pitié-Salpêtrière Hospital, APHP Recruiting
Paris, France
Contact: Anne Bachelot, MD, PhD    33142177832    anne.bachelot@aphp.fr   
Sub-Investigator: Cécile Ghander, MD         
Sub-Investigator: Geoffroy Desbuissons, MD         
Sub-Investigator: Hassan Izzedine, MD, PhD         
Sub-Investigator: Christel Jublanc, MD         
Tenon Hospital, APHP Recruiting
Paris, France
Contact: Jean-Philippe Haymann, MD, PhD    33156016771    jean-philippe.haymann@aphp.fr   
Sub-Investigator: Emmanuel Letavernier, MD, PhD         
Clinic Poitiers Area Recruiting
Poitiers, France
Contact: Pierre Nocent, MD    33549379404    pnocent@gmail.com   
Laennec Hospital Recruiting
Quimper, France
Contact: Tiphaine Roger, MD    33298526076    t.guyon-roger@ch-cornouaille.fr   
Reims University Hospital Recruiting
Reims, France
Contact: Sang Ly, MD    33326787878    tly@chu-reims.fr   
Sub-Investigator: Antoine Braconnier, MD, MSc         
Clinic Rennes Area Recruiting
Rennes, France
Contact: Denis Pinsard, MD    33223300130    depinsard@orange.fr   
Charles Nicolle Hospital Recruiting
Rouen, France
Contact: Ferielle Louillet, MD    33232888990    ferielle.louillet@chu-rouen.fr   
Clinique du Landy Recruiting
Saint-Ouen, France
Contact: Laurence Nicolet, MD    33149458005    laurence.nicolet@fsef.net   
Hautepierre Hospital Recruiting
Strasbourg, France
Contact: Rose-Marie Javier, MD    33388116788    rose-marie.javier@chru-strasbourg.fr   
Sainte Anne Hospital, HIA Recruiting
Toulon, France
Contact: Julie Beaume, MD    33483162340    julie.beaume@gmail.com   
Larrey Hospital Recruiting
Toulouse, France
Contact: Delphine Vezzosi, MD, PhD    33567771701    vezzosi.d@chu-toulouse.fr   
Guy Chatiliez Hospital Recruiting
Tourcoing, France
Contact: Anne-Sophie Balavoine, MD    33320694949    asbalavoine@ch-tourcoing.fr   
Bretonneau Hospital Recruiting
Tours, France
Contact: Peggy Pierre, MD    33247479816    pierre@med.univ-tours.fr   
Sub-Investigator: Lise Crinière, MD         
Sub-Investigator: Elise Pinto Da Rocha, MD         
Valenciennes Hospital Recruiting
Valenciennes, France
Contact: Miriam Ladsous, MD    33327143333    ladsous-m@ch-valenciennes.fr   
Sub-Investigator: Marc Ulrich, MD         
CHIV - Lucie et Raymond Aubrac Recruiting
Villeneuve-Saint-Georges, France
Contact: Anne-Marie Oudrer, MD    33143862000    anne-marie.marteil-oudrer@chiv.fr   
Sponsors and Collaborators
European Georges Pompidou Hospital
Investigators
Principal Investigator: Jean-Philippe Bertocchio, MD, PhD European Georges Pompidou Hospital, APHP; Paris Descartes University, University of Medicine, Paris

Responsible Party: Jean-philippe Bertocchio, MD, PhD, European Georges Pompidou Hospital
ClinicalTrials.gov Identifier: NCT02838927     History of Changes
Other Study ID Numbers: EpiHypo
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean-philippe Bertocchio, European Georges Pompidou Hospital:
Hypoparathyroidism
Epidemiology
Medication Therapy Management

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases