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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Growth Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Growth Hormone

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

No interventions assigned to this group

Healthy Children

Children with normal stature ages 3-18 years.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ambika Ashraf, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ambika Ashraf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

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X3395n

Identifier Type: -

Identifier Source: secondary_id

Genentech X3395n

Identifier Type: OTHER_GRANT