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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by University of Rostock.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473187
First Posted: May 14, 2007
Last Update Posted: May 14, 2007
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.
Information provided by:
University of Rostock
May 11, 2007
May 14, 2007
May 14, 2007
August 2004
Not Provided
change of body proportion and final height [ Time Frame: within 5 years ]
Same as current
No Changes Posted
side effects of therapy with rhGH [ Time Frame: within 5 years ]
Same as current
Not Provided
Not Provided
 
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypophosphatemic Rickets
  • Growth Disorders
  • Somatropin Therapy
Drug: somatropin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
August 2009
Not Provided

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
Sexes Eligible for Study: All
3 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00473187
UKJ-Haffner-XLHR-08-2004
Not Provided
Not Provided
Not Provided
Not Provided
University of Rostock
Not Provided
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
University of Rostock
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP