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
ConditionsX Linked Hypophosphatemic Rickets
Interventionsnorditropine simplex
Drugsnorditropine simplex
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.
Investigators
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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