drugset / Trial / NCT00022841

Prevention of Steroid-Induced Osteoporosis in Children

NCT00022841

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
Primary completion
Completion
2005-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamidronate Small molecule 1 mg/kg Intravenous
Subject Pamidronate Small molecule 30 mg/kg Intravenous

Indications