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

The University of Alabama at Birmingham

Status: Completed

Conditions: Growth Disorders

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00334945

X041104010

X3395n

Genentech X3395n (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Growth Hormone

Description:

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

Healthy Children

Description:

Children with normal stature ages 3-18 years.