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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