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

Growth Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334945
• Other study ID #: X041104010
• Secondary ID: X3395nGenentech
• Status: Completed
• Phase: N/A
• First received: June 7, 2006
• Last updated: November 11, 2011
• Start date: April 2006
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 14 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Growth Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Genentech, Inc.