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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 : July 9, 2019
Sponsor:
Collaborator:
Oscar - Filière Santé Maladies Rares
Information provided by (Responsible Party):
Jean-philippe Bertocchio, European Georges Pompidou Hospital

Tracking Information
First Submitted Date July 9, 2016
First Posted Date July 20, 2016
Last Update Posted Date July 9, 2019
Study Start Date July 2016
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02838927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 17, 2016)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2016)
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Survey on Epidemiology of Hypoparathyroidism in France
Official Title Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients for whom hypoparathyroidism is diagnosed in France
Condition Hypoparathyroidism
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Hypoparathyroidism
No intervention.
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 6, 2019)
1000
Original Estimated Enrollment
 (submitted: July 17, 2016)
500
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02838927
Other Study ID Numbers EpiHypo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jean-philippe Bertocchio, European Georges Pompidou Hospital
Study Sponsor European Georges Pompidou Hospital
Collaborators Oscar - Filière Santé Maladies Rares
Investigators
Principal Investigator: Jean-Philippe Bertocchio, MD, PhD European Georges Pompidou Hospital, APHP
PRS Account European Georges Pompidou Hospital
Verification Date July 2019