Pharmacodynamics of CNP During Growth Hormone Treatment

Completed

Conditions studied: Pituitary Dwarfism, Idiopathic Short Stature

In brief

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.

Key facts

Study ID

NCT01504802

Run by

Nemours Children's Clinic

People needed

22

Starts

2010-11-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-02

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 3 years
• Prepubertal
• Height SD score less than -2.25
• Had a growth hormone stimulation test

You may not qualify if…

• History of any other disease or drug treatment that might interfere with linear growth, including amphetamine derivatives for treatment of ADD or ADHD
• Previous treatment with any growth-promoting medication, including growth hormone
• Any contraindication to growth hormone therapy
• Minor acute illness (upper respiratory infections, strep throat, gastroenteritis, urinary tract infection, etc.) less than one month prior to starting growth hormone
• Major acute illness (pneumonia, meningitis, pyelonephritis, any illness requiring hospitalization, etc.), any surgery, or bone fracture less than six months prior to starting growth hormone
• Weight less than 13 kg (NCC-J) or 15 kg (CHLA), due to blood volume being drawn.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Nemours Children Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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