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

Study Overview
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Brief Summary
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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.

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

Conditions
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Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism

Intervention / Treatment
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* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: somatropin<br>* Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |