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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 7, 2006

Last Updated Date

April 24, 2007

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00334945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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 23 has recently been recognized to help kidneys control phosphate levels.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Longitudinal, Case Control, Prospective Study

Condition ^†

Growth Disorders

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Both

Ages

3 Years to 14 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Tammi L Skelton, RN, BSN

205-939-9107

tskelton@peds.uab.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00334945

Responsible Party

Secondary IDs ^††

X3395n

Study Sponsor ^†

University of Alabama at Birmingham

Collaborators ^††

Genentech

Investigators ^†

Principal Investigator:

Kenneth L McCormick, MD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.