American Norditropin Studies - Registry of Growth Hormone (GH) Patients (ANSWERProg)
The Norditropin National Registry is a post-marketing registry of patients using Norditropin therapy.
A large body of data will be generated to meet the following Registry Objectives:
- To develop a pharmacodynamic model defining the relationship of Norditropin dose to IGF changes, accounting for effects of known or suspected independent variables such as age, gender and puberty
- To develop a model defining the relationship of GH dose and IGF exposure to treatment outcomes, accounting for effects of known or suspected independent variables such as age, gender and puberty
- To develop a safety model that related GH doses to adverse even occurrence, again accounting for the effects of known or suspected independent variables
- To determine the relative predictive values of pre-treatment GH stimulation tests and pre-treatment IGF-I and IGFBP-3 levels
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149|
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||May 2017|
Norditropin Growth Hormone patients
Drug: Norditropin Growth Hormone
Patients are on Norditropin Growth Hormone
Other Name: Norditropin Growth Hormone Resigtry
Patients will be enrolled at the time of initiation of therapy and followed throughout their course of therapy. All patients will be followed in the Division of Pediatric Endocrinology at Duke. Questions regarding medical history, race (or ethnic origin), sex (male or female), growth history, any previous growth deficiency medication, parental height(s), and other medications currently being taken will be asked. A physical examination, consisting of height and weight measurements and pubertal status (maturing of various reproductive organs) will be determined. In addition, at the discretion of the physician, the child may have a determination of bone age (usually measured annually by X-ray as part of routine care), Post-treatment height measurements will be collected, as available, until epiphyseal closure is achieved.
A web-based registry data collection tool with built-in data query resolution for the rapid and accurate collection of data obtained during the course of the Norditropin therapy will be available to participating physicians. .
Participating physicians will make all treatment decisions. The data collected in the Norditropin National Registry will thus be observational as no treatment specifics will be mandated. No additional laboratory studies or x-rays will be ordered other than those necessary for routine care.
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Nancy E. Friedman, MD||Duke University|