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Sponsors and Collaborators: |
Duke University Novo Nordisk |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00615953 |
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:
Condition | Intervention |
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Growth Hormone Deficiency |
Drug: Norditropin Growth Hormone |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149 |
Estimated Enrollment: | 39 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2017 |
Groups/Cohorts | Assigned Interventions |
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1
Norditropin GH patients
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Drug: Norditropin Growth Hormone
Patients are on Norditropin Growth Hormone
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients on Norditropin Growth Hormone
Inclusion Criteria:
Exclusion Criteria:
Contact: Nancy E. Friedman, MD | 919-855-0306 | fried002@mc.duke.edu |
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 |
Principal Investigator: | Nancy E. Friedman, MD | Duke University |
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 |
GH Registry Norditropin National Registry |
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 |
Nervous System Diseases |