Constructing an Insulin-Like Growth Factor-based Prediction Model

NCT00263445 | Terminated

• 2 other identifiers: 04-07-052-02304-F02/X3270n (Genentech)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Deficiency; Idiopathic Short Stature; Small for Gestational Age

Keywords

Growth hormone dosing; IGF-I

Outcome Measures

Primary Outcomes (1)

• Delta IGF-I SDS

  1 SDS change per 20% dose change

  3-months

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

GH-treated chlidren

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Pediatric Endocrinology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Pinchas Cohen, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor and Chief, Peds Endo

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 8, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)