An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

Study Overview
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Brief Summary
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This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.

Official Title
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A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)

Conditions
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Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: somatropin
* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe acquired growth hormone deficiency No treatment with somatropin in the last 24 months before study participation Written informed consent Exclusion Criteria: Contraindications for the treatment with somatropin

Ages Eligible for Study
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Minimum 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>* For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|
| B<br> | Other: No treatment given<br>* Control group not receiving treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (SF-36; EQ-5D) |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Disease related absences from work |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Bone mineral density DXA Z-score lumbar |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Total cholesterol, HDL, LDL |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Body composition: fat mass, fat-free mass, impedance (BIA) |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Waist-circumference |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Blood pressure |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Adverse Drug Reactions and Severe Adverse Drug Reactions |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Triceps skinfold thickness |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| Upper arm circumference |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation | 
| IGF-I (Insulin-like growth factor 1) |  | at 0, 3, 6, 12, 18 and 24 months after treatment initiation |