Prevention of Steroid-Induced Osteoporosis in Children
Status:
Terminated
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether the drug pamidronate can safely and
effectively improve bone mineral density in growing children who have bone disease caused by
taking steroid medications. People who take steroid medications called glucocorticoids, like
prednisone or dexamethasone, for long periods almost always have decreased bone density and
are at increased risk of breaking a bone. Research has shown that pamidronate improves bone
density in adults who take glucocorticoids. However, use of pamidronate is not approved in
children because it has not been extensively tested in children. It is possible that children
will have a different response or unique problems with the medication because their bones are
still growing. We will assign all study participants to one of two groups. One group will
receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral
calcium and vitamin D and the other group will receive calcium and vitamin D. The study is
scheduled to run for 36 months, with visits to the study center once every 3 months.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)