Survey on Epidemiology of Hypoparathyroidism in France

Hypoparathyroidism Clinical Trial

— Epi-Hypo  

Official title:

Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838927
• Other study ID #: EpiHypo
• Status: Recruiting
• Start date: July 2016
• Est. completion date: September 2031

Study information

• Verified date: September 2023
• Source: European Georges Pompidou Hospital
• Contact: Jean-Philippe Bertocchio, MD, PhD
• Phone: (+33)156095625
• Email: jpbertocchio[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2031
• Est. primary completion date: September 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
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	Avicenne Hospital, AP-HP	Bobigny
France	Jean Verdier Hospital, AP-HP	Bondy
France	University Hospital	Bordeaux
France	Bourgoin Jallieu Hospital	Bourgoin-Jallieu
France	La Cavale Blanche Hospital	Brest
France	Côte de Nacre Hospital	Caen
France	Henri Mondor Hospital, APHP	Créteil
France	Dax-Côte d'Argent Hospital	Dax
France	University Hospital	Dijon
France	Grenoble Alpes Hospital	Grenoble
France	CHD Vendée	La Roche-sur-Yon
France	Kremlin-Bicêtre Hospital, APHP	Le Kremlin-Bicêtre
France	Le Mans Hospital	Le Mans
France	Libourne Hospital	Libourne
France	Claude Huriez Hospital	Lille
France	Edouard Herriot Hospital, HCL	Lyon
France	La Conception Hospital, AP-HM	Marseille
France	Clinic area	Mérignac
France	Clinic Metz Area	Metz
France	Mercy Hospital	Metz
France	Arnaud de Villeneuve Hospital	Montpellier
France	Brabois Hospital	Nancy
France	University Hospital	Nantes
France	University Hospital	Nice
France	Caremeau Hospital	Nîmes
France	Georges Renon Hospital	Niort
France	Clinic Paris Area	Paris
France	Cochin Hospital, APHP	Paris
France	European Georges Pompidou Hospital, APHP	Paris
France	Lariboisière Hospital, APHP	Paris
France	Necker Hospital, AP-HP	Paris
France	Pitié-Salpêtrière Hospital, APHP	Paris
France	Tenon Hospital, APHP	Paris
France	Clinic Poitiers Area	Poitiers
France	Laennec Hospital	Quimper
France	Reims University Hospital	Reims
France	Clinic Rennes Area	Rennes
France	Charles Nicolle Hospital	Rouen
France	Felix Guyon Hospital	Saint-Denis	La Réunion
France	Clinic Area	Saint-Junien
France	Clinique du Landy	Saint-Ouen
France	Hautepierre Hospital	Strasbourg
France	Sainte Anne Hospital, HIA	Toulon
France	Larrey Hospital	Toulouse
France	Guy Chatiliez Hospital	Tourcoing
France	Bretonneau Hospital	Tours
France	Valenciennes Hospital	Valenciennes
France	CHIV - Lucie et Raymond Aubrac	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital	Oscar - Filière Santé Maladies Rares

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of the physician's management will help describing the habits of french physician who manage hypoparathyroidism in terms of follow-up	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
Primary	Assessment of the epidemiology of patients with hypoparathyroidism in France	Data collected by questionnaire about etiology of hypoparathyroidism, filled by physicians from clinic folders	Through study completion, about 2 years
Secondary	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	At inclusion (under treatment): through study completion, about 2 years
Secondary	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	At inclusion (under treatment): through study completion, about 2 years
Secondary	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	Through study completion, about 2 years