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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02720770
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : March 28, 2016
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
Allocation: N/A
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 ]

Information from the National Library of Medicine

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

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 Identifier (NCT Number):
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Responsible Party: Alessia Usardi, Professor, Bicetre Hospital Identifier: NCT02720770    
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, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
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, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs