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

Novo Nordisk

Status: Completed

Conditions: Pituitary Dwarfism; Growth Hormone Disorder; Hypopituitarism

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01009905

HGH-2149

U1111-1111-1168 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 22,960 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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®

Trial design

22,960 participants in 1 patient group

A

Treatment:

Drug: somatropin