{"groups":[{"description":"Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.","id":"FG000","title":"15 - Minute Infusion"},{"description":"Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.","id":"FG001","title":"30 - Minute Infusion"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"14"}],"type":"Abnormal laboratory value(s)"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Condition no longer requires study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"15"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"13"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"}],"type":"Death"}],"milestones":[{"achievements":[{"comment":"2 Participants in the 15-minute infusion group did not receive study drug.","groupId":"FG000","numSubjects":"90"},{"comment":"1 Participants in the 30-minute infusion group did not receive study drug.","groupId":"FG001","numSubjects":"89"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"88"},{"groupId":"FG001","numSubjects":"88"}],"type":"Safety Population (Including Site 74)"},{"achievements":[{"comment":"Because of GCP violations at Site 74, post-baseline data for 3 patients in this arm were excluded.","groupId":"FG000","numSubjects":"85"},{"comment":"Because of GCP violations at Site 74, post-baseline data for 4 patients in this arm were excluded.","groupId":"FG001","numSubjects":"84"}],"type":"Safety Population (Excluding Site 74)"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"72"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}