Other Clinical Trial - Growth Hormone Treatment in Children NCT02720770

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	March 2016
Source	Bicetre Hospital
Contact	n/a
Is FDA regulated	No
Health authority	France: Committee for the Protection of Personnes
Study type	Interventional

This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.

Recruitment information / eligibility
Status	Completed
Enrollment	19
Est. completion date	January 2011
Est. primary completion date	January 2009
Accepts healthy volunteers	No
Gender	Both
Age group	3 Years to 14 Years
Eligibility	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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Drug:
• norditropine simplex

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Bicetre Hospital

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in height SDS (standard deviation score)		at year one and year two from baseline	No