Back to resultsGrowth Hormone Treatment in Children With Hypophosphatemic Rickets (GH-XLH)
Primary Purpose
X Linked Hypophosphatemic Rickets
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
norditropine simplex
Sponsored by
About this trial
This is an interventional treatment trial for X Linked Hypophosphatemic Rickets focused on measuring growth hormone
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
norditropine simplex
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in height SDS (standard deviation score)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02720770
Brief Title
Growth Hormone Treatment in Children With Hypophosphatemic Rickets
Acronym
GH-XLH
Official Title
Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bicetre Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
X Linked Hypophosphatemic Rickets
Keywords
growth hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
norditropine simplex
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
norditropine simplex
Other Intervention Name(s)
growth hormone
Primary Outcome Measure Information:
Title
change from baseline in height SDS (standard deviation score)
Time Frame
at year one and year two from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28822957
Citation
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.
Results Reference
derived
Learn more about this trial
Growth Hormone Treatment in Children With Hypophosphatemic Rickets
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