What is Adult Growth Hormone Deficiency?
Growth hormone is produced by the pituitary gland which is located at the base of the brain. In children, growth hormone is necessary for linear growth. In adults, growth hormone deficiency has multiple effects, including:
- Altered body composition with increased fat mass and decreased muscle mass
- Decreased exercise capacity
- Increase in LDL cholesterol (bad cholesterol)
- Low bone mineral density
- Decreased psychological well-being
- Decrease in the quality of life
Adult growth hormone deficiency most frequently results from damage to the pituitary gland or hypothalamus caused by a benign (non-cancerous) tumor. It may also be a consequence of childhood onset growth hormone deficiency, brain trauma, cranial irradiation or of an unknown origin.
What is the REAL 1 trial?
Standard growth hormone treatment is given as a daily injection under the skin, and has been shown to be safe and effective in treating growth hormone deficiency. However, the need for daily injections may pose a challenge for patients. In the REAL 1 trial, a new long-acting growth hormone drug, which is taken once weekly, is compared to once daily growth hormone therapy and to a placebo (inactive drug). The purpose is to investigate whether the once weekly growth hormone is safe and effective (reduces symptoms) in people with adult growth hormone deficiency.
These are the qualifications for participation:
1. You are at least 23 years old and no more than 79 years old
2. Have a confirmed diagnosis of growth hormone deficiency with either adult or childhood onset
3. Have not received treatment with growth hormone or other growth factors within the last 6 months (180 days)
Researchers are looking for about 280 people to participate in the REAL 1 research study worldwide with as many as 10 from the Washington University School of Medicine.
The main study includes fifteen study visits conducted at Washington University School of Medicine and one phone visit over 35 weeks. The extension study includes an additional 13 clinic visits and one phone visit over 53 weeks. Study Procedures include: Taking study medication, Blood tests, Vital signs, Physical exams, ECG, bone density scan, adrenal function test, questionnaires.
There will be no costs to your or your insurance provider for the study tests, procedures and study medication. Your parking will be paid for clinic visits. You will receive $35 for each completed visits and up to $1015 if you complete all of the visits for the main and extension study (about 88 weeks).
I’M INTERESTED! WHO DO I CONTACT FOR MORE INFORMATION?
Stacy Hurst, RN at 314-747-3294 or firstname.lastname@example.org
Investigator: Julie Silverstein, MD