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American Norditropin Studies - Registry of Growth Hormone (GH) Patients (ANSWERProg)
This study is currently recruiting participants.
Verified by Duke University, December 2008
Sponsors and Collaborators: Duke University
Novo Nordisk
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00615953
  Purpose

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

Condition Intervention
Growth Hormone Deficiency
Drug: Norditropin Growth Hormone

Genetics Home Reference related topics: pseudoachondroplasia
Drug Information available for: Somatotropin Somatropin
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149

Further study details as provided by Duke University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 39
Study Start Date: May 2007
Estimated Study Completion Date: May 2017
Groups/Cohorts Assigned Interventions
1
Norditropin GH patients
Drug: Norditropin Growth Hormone
Patients are on Norditropin Growth Hormone

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients on Norditropin Growth Hormone

Criteria

Inclusion Criteria:

  • Patients on Norditropin GH

Exclusion Criteria:

  • Patients not on Norditropin GH
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615953

Contacts
Contact: Nancy E. Friedman, MD 919-855-0306 fried002@mc.duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27705
Contact: Nancy E Friedman, MD     919-684-8327     fried002@mc.duke.edu    
Principal Investigator: Nancy E Friedman, MD            
Sponsors and Collaborators
Duke University
Novo Nordisk
Investigators
Principal Investigator: Nancy E. Friedman, MD Duke University
  More Information

Responsible Party: Duke University Medical Center ( Nancy E. Friedman, MC )
Study ID Numbers: Pro00000557, HGH-2149
Study First Received: February 3, 2008
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00615953  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
GH Registry
Norditropin National Registry

Study placed in the following topic categories:
Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009