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Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent

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ClinicalTrials.gov Identifier: NCT00334945
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : November 16, 2011
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus levels in the body. Phosphorus is an important mineral for bone growth. It is well known that growth hormone treatment improves bone density and bone mineral content. The amount of phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been recognized to help kidneys control phosphate levels.

Condition or disease
Growth Disorders

Detailed Description:
This study will compare Fibroblast Growth Factor 23 levels in children with and without growth hormone deficiency. Children with growth hormone deficiency will have levels taken before starting growth hormone replacement and after it has been initiated.

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23 (a Known Phosphaturic Agent)
Study Start Date : April 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Growth Hormone
Patient ages 3-14 years receiving growth hormone for growth hormone deficiency or short stature
Healthy Children
Children with normal stature ages 3-18 years.




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children attending Endocrinology clinics of Children's Hospital of Alabama. Ages are 3-14 years of age.
Criteria

Inclusion Criteria:

  • Twenty children with significant short stature < 3rd percentile, ages 3-14 years, and referred to Children's Hospital of Alabama
  • Normal healthy volunteer children 3-18 years with normal stature

Exclusion Criteria:

  • Patients on medication including GH
  • Patients with concomitant hormonal abnormalities
  • Patients with disorders of calcium and phosphate metabolism
  • Active neoplasms
  • Closed epiphysis
  • Known bone disorders

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): NCT00334945


Sponsors and Collaborators
University of Alabama at Birmingham
Genentech, Inc.
Investigators
Principal Investigator: Ambika Ashraf, MD University of Alabama at Birmingham

Responsible Party: Ambika Ashraf, M.D., Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00334945     History of Changes
Other Study ID Numbers: X041104010
X3395n
Genentech X3395n ( Other Grant/Funding Number: Genentech )
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Ambika Ashraf, M.D., University of Alabama at Birmingham:
Fibroblast Growth Factors
Bone development

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes
Hormones
Mitogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action