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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Rostock.
Recruitment status was  Active, not recruiting
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
First received: May 11, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
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 Intervention Phase
Hypophosphatemic Rickets
Growth Disorders
Somatropin Therapy
Drug: somatropin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Rostock:

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

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

Study Start Date: August 2004
Estimated Study Completion Date: August 2009

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00473187

University Childrens Hospital, Rostock
Rostock, MV, Germany, 18055
Sponsors and Collaborators
University of Rostock
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

ClinicalTrials.gov Identifier: NCT00473187     History of Changes
Other Study ID Numbers: UKJ-Haffner-XLHR-08-2004 
Study First Received: May 11, 2007
Last Updated: May 11, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
X-linked dominant hypophosphatemic rickets
growth disorders
human growth hormone

Additional relevant MeSH terms:
Familial Hypophosphatemic Rickets
Growth Disorders
Rickets, Hypophosphatemic
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Genetic Diseases, Inborn
Hypophosphatemia, Familial
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Musculoskeletal Diseases
Nutrition Disorders
Pathologic Processes
Phosphorus Metabolism Disorders
Renal Tubular Transport, Inborn Errors
Urologic Diseases
Vitamin D Deficiency

ClinicalTrials.gov processed this record on May 23, 2016