A randomized, double-blind, placebo-controlled, multicenter, parallel-group study of one-year duration followed by 2 years of open-label treatment to determine the safety and efficacy of orally administered 2.5 mg or 5.0 mg risedronate in children > 4 to < 16 years old with osteogenesis imperfecta

In collaboration with Wright State University and Miami Valley Hospital of Dayton, OH, we are currently recruiting OI diagnosed children, 4 to 16 years old, for participation in a three-year osteogenesis imperfecta study. The medicine to be tested is risedronate and belongs to a group of medicines called bisphosphonates. This medicine has been shown to increase bone density in adults, while maintaining bone structure and quality, and therefore makes bones less likely to break. Risedronate has been studied in clinical trials involving approximately 16,000 adult patients affected by bone diseases such as osteoporosis. Recently, a study using risedronate was completed in 28 children with osteogenesis imperfecta, which showed that the medicine was well tolerated by children and showed no major side effects.

The study will be done in two parts. During the first year of the study, your child will either receive risedronate or placebo (a tablet containing no study medicine). During the second and third year, all of the children in the study will receive risedronate (no one will be given placebo). The dose will depend on the child's body weight.

All study visits will take place in the BioMedical Imaging Laboratory (BMIL) at Miami Valley Hospital, Dayton, OH. There will be at least ten visits to the hospital over the next 3 years.

There will be no cost to you for participating in this study. We will provide reimbursement for travel and inconvenience at a rate of $40 per visit. Those traveling more than 50 miles to come to the hospital will be reimbursed for mileage; those traveling more than 100 miles will also be reimbursed for lodging expenses, if needed. If you complete the whole study, you will receive an additional $200.

Updated 29 March 2005