Fall 2006 CARES Foundation, Inc.
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Clinical Trials |
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CAH
Steroid Study at Riley Hospital for Children
Our goal is to compare different glucocorticoids in children with CAH in order to optimize growth and control of CAH so as to avoid the consequences of over-treatment and under-treatment.
We are recruiting children who have classic CAH, are not yet in puberty, and are between the ages of 5 and 12 years old. Children will be enrolled at the General Clinical Research Center (GCRC) at Indiana University School of Medicine affiliated with Riley Hospital for Children in Indianapolis, IN. The study lasts for 18 weeks, but requires only 4 visits to Indianapolis. Three of these visits will consist of an overnight stay. Each participant will randomly be on a 6-week course of each glucocorticoid (hydrocortisone, prednisone, or dexamethasone).
All overnight stays, including labs, medications, and participation compensation, will be paid for by the study. If one is traveling a long distance, arrangements can be made to spend the night at the GCRC the night prior to an overnight stay at no cost.
If you are interested in learning more about our study, please contact either Dr. Erica Eugster at (317) 274-3889, or Dr. Todd Nebesio at (317) 274- 3889 or by e-mail (tdnebesi@iupui.edu). |
CAH Study at the University of North
Carolina Karen Jane Loechner, M.D./Ph.D. We are recruiting children with CAH who are 4-12 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) overtreatment 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 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 your local care provider may be available subject to IRB approval. Travel funds available (please inquire for details). |
CAH Volunteers Needed for Natural History Study Principal Investigator: Dr. Deborah Merke, M.D. Pediatric Endocrinologist and Chief of Pediatric Services at the National Institutes of Health Clinical Center, Bethesda, Maryland
We are currently recruiting patients of all ages with CAH (both classic and nonclassic) for a natural history study at the National Institutes of Health (NIH) in Bethesda, Maryland. By studying the natural history of CAH in a large population of patients, we hope to define new aspects of the disease. This will allow us to develop new management and treatment approaches. Participants will be seen as outpatients at the NIH Clinical Center in Bethesda, Maryland and may be seen once, twice, or for ongoing care. Patients seen for a limited number of visits will have a full report sent to their private physician. All testing is free of charge and will include:
For more information or to volunteer, please contact Carol VanRyzin at the NIH at (301) 451-0399. |
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The studies advertised on these pages have appeared in previous editions of the CARES newsletter. We update the clinical trials section of the newsletter and website as studies become available. For an up-to-date list, visit http://www.caresfoundation.org/clinical_trials.html. |
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