HypoparathyroidismEpi-HypoNCT02838927
Survey on Epidemiology of Hypoparathyroidism in France
An observational study of Hypoparathyroidism, run by European Georges Pompidou Hospital at 57 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 3,000 participants
- Where
- 57 sitesFrance
- Study dates
- Jul 2016to Sep 2031
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients for whom hypoparathyroidism is diagnosed in France
Who may be able to join
- patient fro whom chronic hypoparathyroidism is diagnosed
- patient living in France
Who cannot join
- patient who does not want his data to be collected in this registry
- pseudo-hypoparathyroidism
- acute hypoparathyroidism
Trial locations and contacts
57 sites in 1 country. Contact the study team or a site near you to ask about taking part.
57 sites in 1 country
France57 sites, 57 recruiting
- Recruiting
Hôpital Privé de Provence
Aix-en-Provence, 13100
Nicolas Dervaux, MD
- Recruiting
Amiens University Hospital
Amiens, 80054
Rachel Desailloud, MD, desailloud.rachel@chu-amiens.fr
- Recruiting
Clinic Auch Area
Auch
Stéphane Castillo-Ros, MD, 33562051340, stephane.castillo-ros@wanadoo.fr
- Recruiting
Henri Mondor Hospital
Aurillac
Emmanuelle Dubosclard-Laguerre, MD, 33471465658, e.dubosclard@ch-aurillac.fr
- Recruiting
Jean Minjoz Hospital
Besançon
Sophie Borot, MD, 33381668166, sophie.borot@univ-fcomte.fr
- Recruiting
Blanquefort
Blanquefort
Nathalie Ronci, MD, 800-555-5555, docteur.ronci@orange.fr
- Recruiting
Avicenne Hospital, AP-HP
Bobigny, 93000
Lucie Allard, MD, lucie.allard@aphp.fr
- Recruiting
Jean Verdier Hospital, AP-HP
Bondy
Paul Elie Valensi, MD, PhD, 331 48 95 51 51, paul.valensi@aphp.fr
- Recruiting
University Hospital
Bordeaux
Antoine Tabarin, MD, PhD, 335 24 54 90 08, antoine.tabarin@chu-bordeaux.fr
Renaud de La Faille, MD, PhD
- Recruiting
Bourgoin Jallieu Hospital
Bourgoin
Louis De Laforcade, MD, ldelaforcade@gmail.com
- Recruiting
La Cavale Blanche Hospital
Brest
Morgane Gosselin, MD, 332 98 34 70 74, morgane.gosselin@gmail.com
Véronique Kerlan, MD
- Recruiting
Côte de Nacre Hospital
Caen
Yves Reznik, MD, PhD, 33231064575, reznik-y@chu-caen.fr
- Recruiting
Henri Mondor Hospital, APHP
Créteil
Thomas Stehle, MD, 33149812457, thomas.stehle@aphp.Fr
Céline Droumaguet, MD
- Recruiting
Dax-Côte d'Argent Hospital
Dax
Emmanuelle Bourrinet, MD, 33558914848, bourrinete@ch-dax.fr
- Recruiting
University Hospital
Dijon
Sylvie Picard, MD, 33380702090, doc.sylvie.picard.md@orange.fr
Bruno Vergès, MD, PhD
- Recruiting
Grenoble Alpes Hospital
Grenoble
Olivier Chabre, MD, PhD, 33476765509, olivierchabre@chu-grenoble.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Anne-Hélène Querard, MD, anne-helene.querard@chd-vendee.fr
- Recruiting
Kremlin-Bicêtre Hospital, APHP
Le Kremlin-Bicêtre
Agnès Linglart, MD, PhD, 33145217846, agnes.linglart@aphp.fr
Peter Kamenicky, MD, PhD
- Recruiting
Le Mans Hospital
Le Mans
Anne Dorange, MD, 33243479933, anne.recton@neuf.fr
- Recruiting
Libourne Hospital
Libourne
Adrien Keller, MD, 33557553462, adrien.keller@ch-libourne.fr
- Recruiting
Claude Huriez Hospital
Lille
Marie-Christine Vantyghem, MD, PhD, 33320445962, mc-vantyghem@chru-lille.fr
- Recruiting
Edouard Herriot Hospital, HCL
Lyon
Sandrine Lemoine, MD, PhD, 33437538062, sandrine.lemoine01@chu-lyon.fr
Justine Bacchetta, MD, PhD
- Recruiting
La Conception Hospital, AP-HM
Marseille
Thierry Brue, MD, PhD, Thierry.BRUE@ap-hm.fr
Mickaël Bobot, MD
- Recruiting
Clinic area
Mérignac
Anne Navaranne-Roumec, MD, docteur.navarranne-roumec@orange.fr
- Recruiting
Clinic Metz Area
Metz
Valérie Aubert, MD, 33387358132, dr.valerie.aubert@orange.fr
- Recruiting
Mercy Hospital
Metz
Benjmain Savenkoff, MD, 33387345100, benjamin.savenkoff@gmail.com
Pierre Filipozzi, MD
- Recruiting
Arnaud de Villeneuve Hospital
Montpellier
Cyril Amouroux, MD, 33467336733, cyril-amouroux@chu-montpellier.fr
Isabelle Raingeard, MD
- Recruiting
Brabois Hospital
Nancy
Marc Klein, MD, PhD, 33383153030, m.klein@chru-nancy.fr
- Recruiting
University Hospital
Nantes
Lucile Figueres, MD, PhD, 33240087453, lucile.figueres@chu-nantes.fr
- Recruiting
University Hospital
Nice, 06200
Nicolas Chevalier, MD, PhD
Eléanore Fagot, MD
- Recruiting
Caremeau Hospital
Nîmes
Sophie Renaud, MD, PhD, 33466686868, sophie.renaud@chu-nimes.fr
Olivier Moranne, MD, PhD
- Recruiting
Georges Renon Hospital
Niort, 79000
Claire Laurent, MD, +335 49 32 79 79, claire.laurent@ch-niort.fr
- Recruiting
European Georges Pompidou Hospital, APHP
Paris, 75908
Jean-Philippe Bertocchio, MD, PhD, (+33)156095625, jpbertocchio@gmail.com
Pascal Houillier, MD, PhD, (+33)156095625, pascal.houillier@aphp.fr
- Recruiting
Clinic Paris Area
Paris
Aurélie Rousseau, MD, 33177456764, aurelie.rousseau15@gmail.com
Jean-Marie Garcin, MD
- Recruiting
Cochin Hospital, APHP
Paris
Jérôme Bertherat, MD, PhD, 33158411919, jerome.bertherat@aphp.fr
Lionel Groussin, MD, PhD
- Recruiting
Lariboisière Hospital, APHP
Paris
Jean-Pierre Riveline, MD, 33149959072, jeanpierre.riveline@aphp.fr
Martine Cohen-Solal, MD, PhD
- Recruiting
Necker Hospital, AP-HP
Paris
Bertrannd Knebelmannn, MD, PhD, 33 1 44 49 54 58, bertrand.knebelmann@aphp.fr
Christophe Legendre, MD, PhD
- Recruiting
Pitié-Salpêtrière Hospital, APHP
Paris
Anne Bachelot, MD, PhD, 33142177832, anne.bachelot@aphp.fr
Cécile Ghander, MD
- Recruiting
Saint-Louis Hospital, AP-HP
Paris
Cecile Chougnet, MD, 800-555-5555, cecile.chougnet@aphp.fr
- Recruiting
Tenon Hospital, APHP
Paris
Jean-Philippe Haymann, MD, PhD, 33156016771, jean-philippe.haymann@aphp.fr
Emmanuel Letavernier, MD, PhD
- Recruiting
Passy Hospital
Passy
Matthieu Jamme, MD, PhD, 800-555-5555, mat.jamme@gmail.com
- Recruiting
Clinic Poitiers Area
Poitiers
Pierre Nocent, MD, 33549379404, pnocent@gmail.com
- Recruiting
Laennec Hospital
Quimper
Tiphaine Roger, MD, 33298526076, t.guyon-roger@ch-cornouaille.fr
- Recruiting
Reims University Hospital
Reims
Sang Ly, MD, 33326787878, tly@chu-reims.fr
Antoine Braconnier, MD, MSc
- Recruiting
Clinic Rennes Area
Rennes
Denis Pinsard, MD, 33223300130, depinsard@orange.fr
Johnathan Chemouny, MD, PhD
- Recruiting
Charles Nicolle Hospital
Rouen
Ferielle Louillet, MD, 33232888990, ferielle.louillet@chu-rouen.fr
- Recruiting
Felix Guyon Hospital
Saint-Denis, La Réunion
Xavier Debussche, MD, 33262905610, xavier.debussche@chu-reunion.fr
Arabelle Fioconni, MD
- Recruiting
Saint Florent Le Vieil
Saint-Florent-le-Vieil
Mathilde Maurin, MD, 800-555-5555, dr.mathilde.maurin@gmail.com
- Recruiting
Clinic Area
Saint-Junien, 87200
Severine Boqueho, MD, +335 44 00 09 38, severineboqueho@orange.fr
- Recruiting
Clinique du Landy
Saint-Ouen
Laurence Nicolet, MD, 33149458005, laurence.nicolet@fsef.net
- Recruiting
Hautepierre Hospital
Strasbourg
Rose-Marie Javier, MD, 33388116788, rose-marie.javier@chru-strasbourg.fr
- Recruiting
Sainte Anne Hospital, HIA
Toulon
Julie Beaume, MD, 33483162340, julie.beaume@gmail.com
- Recruiting
Larrey Hospital
Toulouse
Delphine Vezzosi, MD, PhD, 33567771701, vezzosi.d@chu-toulouse.fr
- Recruiting
Guy Chatiliez Hospital
Tourcoing
Anne-Sophie Balavoine, MD, 33320694949, asbalavoine@ch-tourcoing.fr
- Recruiting
Bretonneau Hospital
Tours
Peggy Pierre, MD, 33247479816, pierre@med.univ-tours.fr
Lise Crinière, MD
- Recruiting
Valenciennes Hospital
Valenciennes
Miriam Ladsous, MD, 33327143333, ladsous-m@ch-valenciennes.fr
Marc Ulrich, MD
- Recruiting
CHIV - Lucie et Raymond Aubrac
Villeneuve-Saint-Georges
Anne-Marie Oudrer, MD, 33143862000, anne-marie.marteil-oudrer@chiv.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoparathyroidism
- Being tested
- No intervention
- Keywords
- Hypoparathyroidism, Epidemiology, Medication Therapy Management
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Hypoparathyroidism | No intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the epidemiology of patients with hypoparathyroidism in France
Data collected by questionnaire about etiology of hypoparathyroidism, filled by physicians from clinic folders
Measured: Through study completion, about 2 years
Secondary outcomes (3)
Assessment of the biology at inclusion will describe the evolution of the included population from diagnosis to now (inclusion)
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
Measured: At inclusion (under treatment): through study completion, about 2 years
Assessment of the management at inclusion will describe treatment and complications at inclusion
Number of patients with clinical outcomes (complications such as cataract, nephrolithiasis, nephrocalcinosis, and others) and their management at inclusion
Measured: 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
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
Measured: Through study completion, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oscar - Filière Santé Maladies Rares
- Responsible party
- Principal investigator, Jean-philippe Bertocchio, MD, PhD, European Georges Pompidou Hospital
- Investigators
- Jean-Philippe Bertocchio, MD, PhD, Principal investigator, European Georges Pompidou Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838927
- Sponsor's protocol ID
- EpiHypo
- Acronym
- Epi-Hypo
- Status last verified
- Sep 2024
- First submitted
- 9 Jul 2016
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertocchio JP, Grosset N, Groussin L, Kamenicky P, Larceneux F, Lienhardt-Roussie A, Linglart A, Maruani G, Mirallie E, Pattou F, Seervai RNH, Sido C, Silve C, Vilfaillot A, Tabarin A, Vantyghem MC, Houillier P. Practice patterns for chronic hypoparathyroidism: data from patients and physicians in France. Endocr Connect. 2022 Jan 31;11(1):e210350. doi: 10.1530/EC-21-0350.
PubMed 34939939
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France
- ClinicalTrials.gov ID
- NCT02838927
- Acronym / sponsor ID
- Epi-Hypo / EpiHypo
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Epidemiology, Medication Therapy Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Collaborators
- Oscar - Filière Santé Maladies Rares
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoparathyroidism | – | Other: No interventionNo intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients for whom hypoparathyroidism is diagnosed in France
Key inclusion criteria (2 listed)
- patient fro whom chronic hypoparathyroidism is diagnosed
- patient living in France
Key exclusion criteria (3 listed)
- patient who does not want his data to be collected in this registry
- pseudo-hypoparathyroidism
- acute hypoparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Hypoparathyroidism |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Results publication: PubMed 34939939Bertocchio JP, Grosset N, Groussin L, Kamenicky P, Larceneux F, Lienhardt-Roussie A, Linglart A, Maruani G, Mirallie E, Pattou F, Seervai RNH, Sido C, Silve C, Vilfaillot A, Tabarin A, Vantyghem MC, Houillier P. Practice patterns for chronic hypoparathyroidism: data from patients and physicians in France. Endocr Connect. 2022 Jan 31;11(1):e210350. doi: 10.1530/EC-21-0350.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Philippe Bertocchio, MD, PhD principal investigator
European Georges Pompidou Hospital, APHP
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by European Georges Pompidou Hospital at 57 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Bertocchio, MD, PhD (800-555-5555, jpbertocchio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the epidemiology of patients with hypoparathyroidism in France (time frame: Through study completion, about 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.