{"groups":[{"description":"Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks","id":"FG000","title":"Zoledronic Acid"},{"description":"Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks","id":"FG001","title":"Denosumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"316"},{"groupId":"FG001","numSubjects":"310"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"126"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"143"},{"groupId":"FG001","numSubjects":"124"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"36"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"22"}],"type":"Participant request"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"22"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Ineligibility determined"},{"reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"44"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"890"},{"groupId":"FG001","numSubjects":"886"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"878"},{"groupId":"FG001","numSubjects":"878"}],"type":"Received Investigational Product"},{"achievements":[{"groupId":"FG000","numSubjects":"178"},{"groupId":"FG001","numSubjects":"180"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"712"},{"groupId":"FG001","numSubjects":"706"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.","recruitmentDetails":"Participants were enrolled from 21 June 2006 through 16 May 2008"}