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

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University; Novo Nordisk A/S
• Collaborator: Novo Nordisk A/S
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Informed consent obtained

• Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Exclusion Criteria:

• Patients not being treated with Norditropin®

• Patients who have discontinued treatment with Norditropin®

• Known or suspected allergy to Norditropin® or related products

• Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®