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NCT00263445 · ClinicalTrials.gov registry record
Constructing an Insulin-Like Growth Factor-based Prediction Model
A clinical trial, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- 30
- Enrollment target
NCT00263445: Clinical Trial study, sponsored by University of California, Los Angeles.
NCT00263445 is a clinical trial that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00263445 was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
Study Summary
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.
Primary Outcome
1 SDS change per 20% dose change
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-08 |
| Est. Completion | 2012-07 |
Why NCT00263445 stopped before completion
NCT00263445 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00263445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00263445 about?
NCT00263445 is a clinical study titled "Constructing an Insulin-Like Growth Factor-based Prediction Model". 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 ...
What is the current status of trial NCT00263445?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2004-08. Estimated completion is 2012-07.
Who is sponsoring clinical trial NCT00263445?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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