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

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

Sponsors

Lead sponsor: University of Alabama at Birmingham

Collaborator: Genentech, Inc.

Source 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.

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.

Overall Status Completed
Start Date April 2006
Completion Date August 2011
Primary Completion Date June 2010
Study Type Observational
Enrollment 35
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 3 Years

Maximum age: 14 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ambika Ashraf, MD Principal Investigator University of Alabama at Birmingham
Verification Date

November 2011

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alabama at Birmingham

Investigator full name: Ambika Ashraf, M.D.

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Growth Hormone

Description: Patient ages 3-14 years receiving growth hormone for growth hormone deficiency or short stature

Arm group label: Healthy Children

Description: Children with normal stature ages 3-18 years.

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov