Brain Injuries, Growth Hormone Deficiency Dwarfism
Conditions
Brief summary
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
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.
Interventions
GENETICsomatropin
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
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in Quality of Life-Adult Growth Hormone Deficiency Assessment | Months 1 thru 12 |
| Assessment of adverse events | Months 1 thru 12 |
| Change from baseline in waist circumference | Month 12 |
| Change from baseline in Glasgow Outcome Score | Month 12 |
| Change in Quality of Life-Mini-Mental scores | 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 |
| Age and gender specific optimal doses of GH replacement | Months 1 thru 11 |
Countries
United States
Outcome results
None listed