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Thomas Jefferson University

Department of Pediatrics Faculty Papers

2013

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The Nordinet® International Outcome Study And Novonet® Answer Program®: Rationale, Design, And Methodology Of Two International Pharmacoepidemiological Registry-Based Studies Monitoring Long-Term Clinical And Safety Outcomes Of Growth Hormone Therapy (Norditropin®)., Charlotte Höybye, Lars Sävendahl, Henrik Thybo Christesen, Peter Lee, Birgitte Tønnes Pedersen, Michael Schlumpf, John Germak, Judith Ross Apr 2013

The Nordinet® International Outcome Study And Novonet® Answer Program®: Rationale, Design, And Methodology Of Two International Pharmacoepidemiological Registry-Based Studies Monitoring Long-Term Clinical And Safety Outcomes Of Growth Hormone Therapy (Norditropin®)., Charlotte Höybye, Lars Sävendahl, Henrik Thybo Christesen, Peter Lee, Birgitte Tønnes Pedersen, Michael Schlumpf, John Germak, Judith Ross

Department of Pediatrics Faculty Papers

OBJECTIVE: Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice.

DESIGN: The NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data.

PATIENTS: The studies …