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Clinical Trials/NCT02720770
NCT02720770
Completed
Phase 1

Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial

Bicetre Hospital0 sites19 target enrollmentJanuary 2006

Overview

Phase
Phase 1
Intervention
norditropine simplex
Conditions
X Linked Hypophosphatemic Rickets
Sponsor
Bicetre Hospital
Enrollment
19
Primary Endpoint
change from baseline in height SDS (standard deviation score)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
January 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bicetre Hospital
Responsible Party
Principal Investigator
Principal Investigator

Alessia Usardi

Professor

Bicetre Hospital

Eligibility Criteria

Inclusion Criteria

  • clinical, biochemical and genetic diagnosis of XLH
  • height SDS \< 2
  • at least two years of treatment with oral phosphate and calcitriol

Exclusion Criteria

  • uncontrolled rickets (ALP\>600 IU)
  • growth hormone deficiency
  • hyperparathyroidism, nephrocalcinosis, renal insufficiency
  • associated disease
  • previous treatment with growth hormone

Arms & Interventions

norditropine simplex

Intervention: norditropine simplex

Outcomes

Primary Outcomes

change from baseline in height SDS (standard deviation score)

Time Frame: at year one and year two from baseline

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