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American Norditropin Studies - Registry of Growth Hormone (GH) Patients

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Deficiency

Intervention: Norditropin Growth Hormone (Drug)

Phase: N/A

Status: Suspended

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Nancy E. Friedman, MD, Principal Investigator, Affiliation: Duke University


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

Clinical Details

Official title: American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Detailed description: 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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients on Norditropin GH

Exclusion Criteria:

- Patients not on Norditropin GH

Locations and Contacts

Duke University Health System, Durham, North Carolina 27705, United States
Additional Information

Starting date: May 2007
Last updated: June 28, 2011

Page last updated: August 23, 2015

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