Growth Hormone Treatment in Children With Hypophosphatemic Rickets

Phase 1

Completed

• Conditions: X Linked Hypophosphatemic Rickets
• Interventions: Drug: norditropine simplex

• Registration Number: NCT02720770
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-01
• Study Completion: 2011-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Study First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
norditropine simplex	norditropine simplex	-

Primary Outcome Measures

Name	Time	Method
change from baseline in height SDS (standard deviation score)	at year one and year two from baseline