Growth Hormone Treatment in Children With Hypophosphatemic Rickets

Overview

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

Full Title of Study: “Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: norditropine simplex

Arms, Groups and Cohorts

  • Experimental: norditropine simplex

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline in height SDS (standard deviation score)
    • Time Frame: at year one and year two from baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bicetre Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alessia Usardi, Professor – Bicetre Hospital

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