{"groups":[{"description":"Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"FG000","title":"Placebo"},{"description":"Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"FG001","title":"Denosumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"205"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"158"},{"groupId":"FG001","numSubjects":"127"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"17"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"0"}],"type":"Continuing into Zoledronic Acid Substudy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"1709"},{"groupId":"FG001","numSubjects":"1711"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1699"},{"groupId":"FG001","numSubjects":"1700"}],"type":"Received Study Drug in the Double-blind Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"268"},{"groupId":"FG001","numSubjects":"3"}],"type":"Continued Into the Open-Label Phase"},{"achievements":[{"comment":"The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.","groupId":"FG000","numSubjects":"1690"},{"comment":"The safety analysis set was summarized based on the actual treatment received in the double-blind phase. Participants who received at least 1 dose of denosumab in the double-blind phase were summarized in the denosumab group regardless of the randomized treatment.","groupId":"FG001","numSubjects":"1709"}],"type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"1242"},{"groupId":"FG001","numSubjects":"1362"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"467"},{"groupId":"FG001","numSubjects":"349"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in a 1:1 ratio to receive either denosumab or placebo in the double-blind phase. Randomization was stratified by type of hospital (major academic centers or other centers), prior aromatase inhibitor usage (Yes/No) and total lumbar spine bone mineral density (BMD) score at baseline (T-score \\< -1.0 or ≥ -1.0). Willing and eligible participants continued into the open-label phase and receive denosumab for a maximum of 7 doses once Q6M.","recruitmentDetails":"Participants were enrolled at 58 centers in Austria and Sweden from December 2006 to August 2020.\n\nData collected during the exploratory ZA substudy were not used for the final analysis of the main study."}