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Pharmacodynamics of CNP During Growth Hormone Treatment

NCT01504802 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2014-10-02

No results posted yet for this study

Summary

It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. Some children will not respond to growth hormone treatment at all. Currently, the only way to determine how well growth hormone therapy is working is to wait until they have been treated for six months and to compare the pre-treatment growth velocity with the growth velocity on treatment. It would be helpful to have a blood test that could be done shortly after starting growth hormone that could predict whether how well a child is responding to treatment. Such a blood test would allow endocrinologists to adjust the growth hormone dose (or possibly stop it altogether, if it is not working) long before the six months it currently takes.

C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP) are proteins that play a critical role in regulating growth. The investigators have previously shown that blood levels of these proteins increase in children being treated with growth hormone. The investigators believe that a blood test for these proteins will be useful in predicting a child's response to growth hormone treatment.

The purpose of this study is to determine when after starting growth hormone, the blood levels of CNP and NTproCNP start to increase.

Conditions

  • Pituitary Dwarfism
  • Idiopathic Short Stature

Sponsors & Collaborators

Principal Investigators

  • Robert Olney, MD · Nemours Children's Clinic

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504802 on ClinicalTrials.gov