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

This study has suspended participant recruitment.
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Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00615953
First received: February 3, 2008
Last updated: June 28, 2011
Last verified: June 2011
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 79
Study Start Date: May 2007
Estimated Study Completion Date: May 2017
Groups/Cohorts Assigned Interventions
1
Norditropin Growth Hormone patients
Drug: Norditropin Growth Hormone
Patients are on Norditropin Growth Hormone
Other Name: Norditropin Growth Hormone Resigtry

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615953

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Novo Nordisk A/S
Investigators
Principal Investigator: Nancy E. Friedman, MD Duke University
  More Information

No publications provided

Responsible Party: Nancy E. Friedman, MC, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00615953     History of Changes
Other Study ID Numbers: Pro00000557, HGH-2149
Study First Received: February 3, 2008
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
GH Registry
Norditropin National Registry

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014