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Clinical Trials/NCT02720770
NCT02720770CompletedPhase 1

Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial

Bicetre Hospital0 sites19 target enrollmentStarted: January 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
19
Primary Endpoint
change from baseline in height SDS (standard deviation score)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Years to 14 Years (Child)
Sex
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

Arms & Interventions

norditropine simplex

Experimental

Intervention: norditropine simplex (Drug)

Outcomes

Primary Outcomes

change from baseline in height SDS (standard deviation score)

Time Frame: at year one and year two from baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bicetre Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alessia Usardi

Professor

Bicetre Hospital

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