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

Completed

• Conditions: Growth Hormone Disorder; Pituitary Dwarfism; Hypopituitarism
• Interventions: Drug: somatropin

• Registration Number: NCT01009905
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-24
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22960

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®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	somatropin	-

Primary Outcome Measures

Name	Time	Method
Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Change in waist/hip circumference ratio for adult patients	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Secondary Outcome Measures

Name	Time	Method
Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Proportion achieving HSDS of more than -2 at final height	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Weight, waist circumference, and hip circumference for adult patients	measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States