|
Research>>Clinical Trials>>Osteoporosis Study
CAH and Osteoporosis Screening Study
UNC Chapel Hill, North Carolina
WHO: Children with CAH who are 8-12 years old (bone age 14 years) and are still growing. Siblings (6-14 years old, bone age 14 years old) of those children with CAH who otherwise meet the same eligibility criteria except that they do not have CAH and are not on glucocorticoids.
WHY: Although cortisol replacement is essential to treat children with CAH, there is the potential risk of over-treatment with glucocorticoids that can result in abnormal weight gain, decreased linear growth and, more recently reported in adults, the risk of osteoporosis. We are now testing if there exists a risk for osteoporosis in children with CAH and if this risk is related to the dosing of glucocorticoid used, as would be expected with any medical condition in which steroids are required for long-term treatment. We are also examining if the subtype of CAH contributes to the risk for osteoporosis.
WHERE: Children will be enrolled in the study at the General Clinical Research Center at the University of North Carolina, Chapel Hill.
WHAT: Your child would have:
- Bone Age X-ray
- DXA scans (to screen for osteoporosis and for subtle spine fractures).
- Special X-ray of his/her arm to look at the effects of glucocorticoid dosing (Cortef, for example) on bone structure itself
- Blood and urine tests to determine the degree of his/her “control” of CAH
- Blood test for genotyping for all children in the study. In this way, “control” siblings can find out if they are “unaffected” or “carriers.”
WHEN: This would all occur in a one-time visit (3 hours) for your child with CAH and/or sibling.
HOW MUCH: The clinical visit, including laboratory testing, radiologic evaluation and physical exam will be paid for by this protocol. Overnight accommodations can be arranged, a rental car to/from the airport and parking at UNC will be covered. Travel assistance is possible (please inquire for details). There is a $50 compensation provided for incidental costs for each child enrolled.
For more information, contact:
Karen J. Loechner, M.D./Ph.D. (off-site investigator)
Pediatric Endocrinology Unit
Pediatric Osteoporosis Clinic
Dartmouth Hitchock Medical Center 603-740-2366
email: karen_loechner@med.unc.edu;
|
