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
Sponsor:
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00473187
First received: May 11, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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
  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Locations
Germany
University Childrens Hospital, Rostock
Rostock, MV, Germany, 18055
Sponsors and Collaborators
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
  More Information

No publications provided

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
anthropometry
human growth hormone

Additional relevant MeSH terms:
Growth Disorders
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
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

ClinicalTrials.gov processed this record on August 21, 2014