{"groups":[{"description":"Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.","id":"FG000","title":"Placebo"},{"description":"Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.","id":"FG001","title":"Denosumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1524"},{"groupId":"FG001","numSubjects":"1514"}],"type":"Protocol-specified Criteria: Study Ended"},{"reasons":[{"groupId":"FG000","numSubjects":"369"},{"groupId":"FG001","numSubjects":"385"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"215"},{"groupId":"FG001","numSubjects":"214"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"35"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"20"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"20"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"14"}],"type":"Ineligibility Determined"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"11"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"9"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}],"type":"Administrative Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Deviation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"2253"},{"groupId":"FG001","numSubjects":"2256"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2229"},{"groupId":"FG001","numSubjects":"2230"}],"type":"Received Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"28"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2226"},{"groupId":"FG001","numSubjects":"2228"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in a 1:1 ratio to 1 of 2 groups. Randomization was stratified based on breast cancer therapy/lymph node (LN) status, hormone receptor status, human epidermal growth factor receptor 2 (HER-2) status, age, and geographic region.","recruitmentDetails":"Participants were enrolled at 407 centers in Australia, Western Europe, Eastern Europe, Israel, North America, Asia, South America, South Africa, and Turkey from 02 June 2010 to 24 August 2012."}