Constructing an Insulin-Like Growth Factor-based Prediction Model

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Brief Title

Constructing an Insulin-Like Growth Factor-based Prediction Model

Official Title

Constructing an Insulin-Like Growth Factor-based Prediction Model

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.
    

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 patient's age, gender, height, weight, linear height velocity,
      pubertal status, GH dose, IGF-I levels, disease condition (i.e., 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
      change/IGF-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 Type

Observational


Primary Outcome

Delta IGF-I SDS


Condition

Growth Hormone Deficiency



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

30

Start Date

August 2004

Completion Date

July 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Patients being treated with growth hormone for other conditions such as Turner
             syndrome, chronic renal failure, or Prader-Willi syndrome
      

Gender

All

Ages

3 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

Pinchas Cohen, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00263445

Organization ID

04-07-052-02

Secondary IDs

304-F02/X3270n (Genentech)

Responsible Party

Principal Investigator

Study Sponsor

University of California, Los Angeles


Study Sponsor

Pinchas Cohen, MD, Principal Investigator, University of California, Los Angeles


Verification Date

December 2014