Constructing an Insulin-Like Growth Factor-based Prediction Model
Stopped early
Conditions studied: Growth Hormone Deficiency, Idiopathic Short Stature, Small for Gestational Age
In brief
Serum insulin-like growth factor-I (IGF-I) measurements have been shown to correlate well with growth hormone action and effect, and recent data show that serum IGF-I may be related to safety and efficacy of growth hormone (GH) treatment in patients. Some studies indicate that high IGF-I levels are associated with increased cancer risk, and low IGF-I levels are associated with increased risk for cardiovascular disease. Studies in children also show that the serum IGF-I level is correlated with the change in height score achieved (that is, the higher the IGF-I level, the greater the gain in height). Pediatric endocrinologists have therefore begun to use serum IGF-I levels, in addition to growth rate and weight gain, to adjust the GH dose in treated children. Although monitoring of serum IGF-I levels is becoming standard of care in patients begin treated with GH, there are few guidelines regarding the actual logistics of adjusting GH dose. As serum IGF-I level has been linked to both safety and efficacy of GH treatment, the ideal practice would be to maintain serum IGF-I levels within a certain target range. The overall goal of our study is to construct a mathematical model which predicts the change in GH dose necessary to achieve a desired change in IGF-I level. Hypotheses to be tested by our study include the following: IGF-I measurement has a role in optimization of GH therapy; GH dose change to achieve IGF-I changes are predictable; and gender and puberty affect the relationship between dose change and target IGF-I changes.
Key facts
- Study ID
- NCT00263445
- Run by
- University of California, Los Angeles
- People needed
- 30
- Starts
- 2004-08-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2014-12-02
Who can join
Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prepubertal patients,
- Male/female,
- Ages 3-14 yrs,
- Being treated with growth hormone for the conditions of growth hormone deficiency, idiopathic short stature, and small-for-gestational age with failure to catch up to the normal growth curve by age 2 years.
You may not qualify if…
- Patients being treated with growth hormone for other conditions such as Turner syndrome, chronic renal failure, or Prader-Willi syndrome
Where it is running
- UCLA Pediatric Endocrinology — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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