Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets

May 11, 2007 updated by: University of Rostock

Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets

X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Rostock, MV, Germany, 18055
        • University Childrens Hospital, Rostock

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 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tanner stages of puberty B1, G1
  • body height < 2,5 SDS
  • growth velocity < 75%
  • confirmed diagnosis of XLHR
  • conservative treatment for at least 1 year (phosphate, vitamin D)
  • informed consent, written agreement

Exclusion Criteria:

  • growth hormone deficiency
  • hypothyreosis
  • severe rickets
  • severe physical deformities
  • severe hyperparathyreoidism
  • chronic renal failure
  • complex syndrome involving failure to thrive
  • chronic disease with failure to thrive
  • impairment of glucose tolerance
  • Tanner stages of puberty greater than B1, G1
  • medical history of malignancy
  • therapy with growth hormone, glucocorticoides, anabolica
  • attending another clinical trial

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of body proportion and final height
Time Frame: within 5 years
within 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects of therapy with rhGH
Time Frame: within 5 years
within 5 years

Collaborators and Investigators

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

Sponsor

University of Rostock

Investigators

  • Principal Investigator: Dirk Schnabel, MD, University Childrens Hospital - Charite, Berlin
  • Principal Investigator: Hagen Staude, University Childrens Hospital, Rostock
  • Principal Investigator: Dieter Haffner, MD, University Childrens Hospital, Rostock

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

August 1, 2004

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

May 11, 2007

First Submitted That Met QC Criteria

May 11, 2007

First Posted (Estimate)

May 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 14, 2007

Last Update Submitted That Met QC Criteria

May 11, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKJ-Haffner-XLHR-08-2004

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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