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
Summary
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
|