We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00473187
Recruitment Status : Unknown
Verified May 2007 by University of Rostock.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2007
Last Update Posted : May 14, 2007
Sponsor:
Information provided by:
University of Rostock

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypophosphatemic Rickets Growth Disorders Somatropin Therapy Drug: somatropin Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
Study Start Date : August 2004
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. change of body proportion and final height [ Time Frame: within 5 years ]

Secondary Outcome Measures :
  1. side effects of therapy with rhGH [ Time Frame: within 5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473187


Locations
Layout table for location information
Germany
University Childrens Hospital, Rostock
Rostock, MV, Germany, 18055
Sponsors and Collaborators
University of Rostock
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00473187    
Other Study ID Numbers: UKJ-Haffner-XLHR-08-2004
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: May 14, 2007
Last Verified: May 2007
Keywords provided by University of Rostock:
X-linked dominant hypophosphatemic rickets
growth disorders
anthropometry
human growth hormone
Additional relevant MeSH terms:
Layout table for MeSH terms
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Growth Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
 Malnutrition
Nutrition Disorders
Pathologic Processes
Hypophosphatemia
Phosphorus Metabolism Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn