Conditions: Osteogenesis Imperfecta
Keywords: Primary disease: Osteogenesis Imperfecta
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Detailed description:

Arms:
arm 1: placebo tablet, once a day for one year then for two years open label risedronate arm 2: risedronate tablet, once a day for one year then for two years open label risedronate once a day

Interventions: intervention 1: risedronate sodium (Actonel) intervention 2: Placebo
Intervention descriptions: intervention 1: risedronate tablet once a day for one year followed by risedronate once a day for two years intervention 2: placebo tablet once a day for one year followed by risedronate once a day for two years

Protocol document: