Risedronate in the treatment of mild pediatric osteogenesis imperfecta: a randomized placebo-controlled study.

摘要: Intravenous pamidronate is the most widely used treatment for moderate to severe osteo- genesis imperfecta (OI). Currently, there no medical patients with mild OI. We conducted a single-center randomized double-blind placebo-controlled trial examine efficacy and safety of oral risedronate in pediatric A total 26 children adolescents (age, 6.1-17.7 yr; 11 girls) OI type I were either placebo (N = 13) or 2 yr. Risedronate doses 15 mg once per week weighing 40 kg. After yr treatment, decreased serum levels bone resorption marker collagen N-telopeptide by 35% compared 6% reduction (p 0.003). increased lumbar spine areal BMD Z-scores 0.65, whereas receiving ex- perienced decrease 0.15 0.002). In contrast, significant differences mass density found at radial metaphysis diaphysis, hip, body. Histomorphometric analysis transiliac biopsies end study period did not show difference cortical width, trabecular volume, parameters turnover. Similarly, was detectable effect on vertebral morphometry, second metacarpal grip force, pain, number new fractures. Regarding safety, generally well tolerated, inci- dence clinical laboratory adverse experiences similar among groups. These results suggest that skeletal effects are weaker than those commonly observed intravenous but still lead an increase BMD. Future studies should investigate whether effective reducing fracture rates I. J Bone Miner Res 2009;24:1282-1289. Published online February 16, 2009; doi: 10.1359/JBMR.090213