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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00334945
First Posted: June 8, 2006
Last Update Posted: November 16, 2011
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
  Purpose
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
Growth Disorders

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ambika Ashraf, M.D., University of Alabama at Birmingham:

Enrollment: 35
Study Start Date: April 2006
Study Completion Date: August 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: June 7, 2006
First Posted: June 8, 2006
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