Growth Hormone Treatment in Children With Hypophosphatemic Rickets (GH-XLH)

March 22, 2016 updated by: Alessia Usardi, Bicetre Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: norditropine simplex
Drug: norditropine simplex
Other Names:
  • growth hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in height SDS (standard deviation score)
Time Frame: at year one and year two from baseline
at year one and year two from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bicetre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM 03-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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