AN INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL EFFICACY AND

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this trial is to assess the percentage change in lumbar spine bone mineral density at month 12 relative to baseline in zoledronic acid treated patients with severe osteogenesis imperfecta compared to pamidronate treated patients. The efficacy of zoledronic acid will be demonstrated if it is shown to be not inferior to pamidronate (i.e. the percentage change from baseline in bone mineral density after 12 months is less than 13% inferior to pamidronate). Secondary efficacy objectives: -To assess the z score of the lumbar spine at month 12 in zoledronic acid (0.05 mg/kg) treated patients with severe osteogenesis imperfecta compared to pamidronate (3.0 mg/ kg) treated patients -To assess the effect of zoledronic acid on the number of clinical fractures that occur over a one year period compared to pamidronate