| Spring 2004 CARES Foundation, Inc. | |
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CAH Study at UNC Chapel Hill, North Carolina by Karen Jane Loechner, M.D./Ph.D.
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| We are recruiting children with CAH who are 6-12 years old (bone age <14 years), are still growing, and have not yet started puberty. Children will be enrolled in the study at the General Clinical Research Center at the University of North Carolina, Chapel Hill.
Although cortisol replacement (hydrocortisone, prednisone, or dexamethasone, for example) and florinef have virtually eliminated mortality, there are at least two reasons for continuing to try to perfect our treatment regimens: (1) the linear growth of children is suboptimal and the end result is an adult who is too short, and (2) over-treatment with glucocorticoids in children may increase risk of osteoporosis in later years. Based on studies of the regulation of release of ACTH (that, in turn, drives the production of hormones from the adrenal cortex), we have found that we can decrease the amount of ACTH using calcium channel blockers (medications typically used to treat high blood pressure, such as amlodipine). Amlodipine has been shown to be safe even in infants treated for a variety of medical reasons. Our hypothesis is that the addition of amlodipine will allow us to decrease the amount of glucocorticoid medication that your child is currently taking to control his/her CAH. Such a decrease should translate into better growth and bone strength. This new medication would be added to your child’s current CAH treatment program and evaluated in a double-blind/placebo-controlled crossover study. For more information, please contact Dr. Karen Loechner at (919) 216-5946 (pager) or (919) 966-4435 ext. 224 (voice mail); fax (919) 966-2423; Roxanne Schock, CDE, Clinical Coordinator at (919) 966-0428 (voice mail). All visits, including laboratory testing, research medication, and parking will be paid for by this protocol. Limited "off-site" testing at local Pediatric Endocrinologist may be available subject to IRB approval. |
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