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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.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE March 28, 2016
Last Update Posted Date March 28, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
change from baseline in height SDS (standard deviation score) [ Time Frame: at year one and year two from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth Hormone Treatment in Children With Hypophosphatemic Rickets
Official Title  ICMJE Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE X Linked Hypophosphatemic Rickets
Intervention  ICMJE Drug: norditropine simplex
Other Name: growth hormone
Study Arms  ICMJE Experimental: norditropine simplex
Intervention: Drug: norditropine simplex
Publications * Rothenbuhler A, Esterle L, Gueorguieva I, Salles JP, Mignot B, Colle M, Linglart A. Two-year recombinant human growth hormone (rhGH) treatment is more effective in pre-pubertal compared to pubertal short children with X-linked hypophosphatemic rickets (XLHR). Growth Horm IGF Res. 2017 Oct;36:11-15. doi: 10.1016/j.ghir.2017.08.001. Epub 2017 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2016)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02720770
Other Study ID Numbers  ICMJE RBM 03-47
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alessia Usardi, Bicetre Hospital
Study Sponsor  ICMJE Bicetre Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bicetre Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP