Observational Prospective Study on Patients Treated With Norditropin®

Study Overview
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Brief Summary
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This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Official Title
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NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

Conditions
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Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic Disorder, Turner Syndrome, Foetal Growth Problem, Small for Gestational Age, Chronic Kidney Disease, Chronic Renal Insufficiency, Noonan Syndrome

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Judged by the physician as per the Norditropin® label Exclusion Criteria: Judged by the physician as per the Norditropin® label
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>Adult cohort | Drug: somatropin<br>* The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.<br>|
| B<br>Paediatric cohort | Drug: somatropin<br>* The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Norditropin® treatment on height gain (change in height) in children |  | Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. | 
| Effect of Norditropin® treatment on body weight and body composition in adults |  | Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children |  | Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. | 
| Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults |  | Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. |