NCT00334945

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

4.2 years

First QC Date

June 7, 2006

Last Update Submit

November 11, 2011

Conditions

Growth Disorders

Keywords

Fibroblast Growth FactorsBone development

Study Arms (2)

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.

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children attending Endocrinology clinics of Children's Hospital of Alabama. Ages are 3-14 years of age.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ambika Ashraf, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2010

Study Completion

August 1, 2011

Last Updated

November 16, 2011

Record last verified: 2011-11