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Growth Hormone Treatment in Children With Hypophosphatemic Rickets (GH-XLH)

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ClinicalTrials.gov Identifier: NCT02720770
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
Alessia Usardi, Bicetre Hospital

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.

Condition or disease Intervention/treatment Phase
X Linked Hypophosphatemic Rickets Drug: norditropine simplex Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial
Study Start Date : January 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2011


Arm Intervention/treatment
Experimental: norditropine simplex Drug: norditropine simplex
Other Name: growth hormone




Primary Outcome Measures :
  1. change from baseline in height SDS (standard deviation score) [ Time Frame: at year one and year two from baseline ]


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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alessia Usardi, Professor, Bicetre Hospital
ClinicalTrials.gov Identifier: NCT02720770     History of Changes
Other Study ID Numbers: RBM 03-47
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alessia Usardi, Bicetre Hospital:
growth hormone
Additional relevant MeSH terms:
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Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia
Phosphorus Metabolism Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs