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

This study has been completed.

First Received on June 7, 2006. Last Updated on November 11, 2011 History of Changes

Sponsor:	University of Alabama at Birmingham
Collaborator:	Genentech
Information provided by (Responsible Party):	Ambika Ashraf, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00334945

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:

MedlinePlus related topics: Growth Disorders

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:	3 Years to 14 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334945

Sponsors and Collaborators

University of Alabama at Birmingham

Genentech

Investigators

Principal Investigator:

Ambika Ashraf, MD

University of Alabama at Birmingham

More Information

No publications provided

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
Study First Received:	June 7, 2006
Last Updated:	November 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Fibroblast Growth Factors
Bone development

Additional relevant MeSH terms:

Growth Disorders
Pathologic Processes
Mitogens
Hormones
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012