A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

Study Overview
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Brief Summary
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The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury

Detailed Description
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The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Official Title
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Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury

Conditions
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Brain Injuries, Growth Hormone Deficiency Dwarfism

Intervention / Treatment
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* Genetic: somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented GHD Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure) Exclusion Criteria: Active systemic malignancy or active intracranial tumor Growth hormone replacement therapy in the last 12 months History of dementia unrelated to traumatic brain injury

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Genetic: somatropin<br>* Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline |  | Months 1 thru 11 | 
| Number of patients with abnormal GH stimulation tests |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in waist circumference |  | Month 12 | 
| Age and gender specific optimal doses of GH replacement |  | Months 1 thru 11 | 
| Change in Quality of Life-Adult Growth Hormone Deficiency Assessment |  | Months 1 thru 12 | 
| Assessment of adverse events |  | Months 1 thru 12 | 
| Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies |  | Baseline | 
| Change from baseline in Glasgow Outcome Score |  | Month 12 | 
| Change in Quality of Life-Mini-Mental scores |  | Months 1 thru 12 |