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

Growth Hormone Deficiency Clinical Trial

— ANSWERProg  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00615953
• Other study ID #: Pro00000557
• Secondary ID: HGH-2149
• Status: Suspended
• Phase: N/A
• First received: February 3, 2008
• Last updated: June 28, 2011
• Start date: May 2007
• Est. completion date: May 2017

Study information

• Verified date: June 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 79
• Est. completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients on Norditropin GH

Exclusion Criteria:

• Patients not on Norditropin GH

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• Norditropin Growth Hormone
Patients are on Norditropin Growth Hormone

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Novo Nordisk A/S

Country where clinical trial is conducted

United States,