Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263445
Status:
TERMINATED
Last Update Posted:
2014-12-02
First Post:
2005-12-07
Brief Title:
Constructing an Insulin-Like Growth Factor-based Prediction Model
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Constructing an Insulin-Like Growth Factor-based Prediction Model
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The first phase of our study previously approved by the UCLA IRB in August 2004 involved a retrospective chart review and collection of preexisting data We analyzed charts of patients who underwent non-weight-based GH dose adjustments preceded and followed by a serum IGF-I level Data collected included patients age gender height weight linear height velocity pubertal status GH dose IGF-I levels disease condition ie growth hormone deficiency idiopathic short stature small-for-gestational age and recording of any adverse effects Based on this data collected we performed statistical analysis of the relationship between GH dose change and change in IGF-I level achieved and have found that in prepubertal children there is a significant relationship between the GH dose change and change in corresponding IGF-I level We have subsequently constructed a mathematical prediction model that allows us to determine the GH dose change necessary to achieve a desired IGF-I level and in this second phase of our study we plan to apply this mathematical prediction model prospectively for guiding GH dose adjustments in prepubertal children being treated with GH therapy
Children being treated with GH are typically followed in the outpatient Endocrinology clinic every 3-4 months and our practitioners have routinely been obtaining serum IGF-I levels via venipuncture in the outpatient laboratory for monitoring purposes Validation of our GH dose changeIGF-I change prediction model will require assessment of sequential serum IGF-I level measurements immediately preceding a GH dose change and again within 1-4 months following the GH dose change We plan to continue our retrospective and ongoing analysis of patients who have paired values of GH dose adjustments preceded and followed by a serum IGF-I level in order that we may continue to fine-tune our prediction model for optimizing GH dose adjustments
Children being treated with GH are typically followed in the outpatient Endocrinology clinic every 3-4 months and our practitioners have routinely been obtaining serum IGF-I levels via venipuncture in the outpatient laboratory for monitoring purposes Validation of our GH dose changeIGF-I change prediction model will require assessment of sequential serum IGF-I level measurements immediately preceding a GH dose change and again within 1-4 months following the GH dose change We plan to continue our retrospective and ongoing analysis of patients who have paired values of GH dose adjustments preceded and followed by a serum IGF-I level in order that we may continue to fine-tune our prediction model for optimizing GH dose adjustments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 304-F02X3270n Genentech | None | None | None |