Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent
This study has been completed.
Information provided by (Responsible Party):
Ambika Ashraf, M.D., University of Alabama at Birmingham
First received: June 7, 2006
Last updated: November 11, 2011
Last verified: November 2011
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23 (a Known Phosphaturic Agent)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
Patient ages 3-14 years receiving growth hormone for growth hormone deficiency or short stature
Children with normal stature ages 3-18 years.
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.
|Ages Eligible for Study:
||3 Years to 14 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Children attending Endocrinology clinics of Children's Hospital of Alabama. Ages are 3-14 years of age.
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00334945
University of Alabama at Birmingham
||Ambika Ashraf, MD
||University of Alabama at Birmingham
No publications provided
||Ambika Ashraf, M.D., Principal Investigator, University of Alabama at Birmingham
History of Changes
|Other Study ID Numbers:
||X041104010, X3395n, Genentech X3395n
|Study First Received:
||June 7, 2006
||November 11, 2011
||United States: Institutional Review Board
Keywords provided by University of Alabama at Birmingham:
Fibroblast Growth Factors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs