NCT01009905

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22,960 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

Conditions

• Growth Hormone Disorder
• Pituitary Dwarfism
• Hypopituitarism

Interventions

Type	Name	Description
DRUG	somatropin	Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice

Timeline

• Start date: 2002-06-24
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2009-11-09
• Last updated: 2017-04-12

Locations

1 site across 1 country: United States