{"groups":[{"description":"Participants with surgically unsalvageable disease (eg, sacral, spinal giant cell tumor of bone (GCTB), or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 milligrams (mg) subcutaneously (SC) once every 4 weeks (Q4W), starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.","id":"FG000","title":"Cohort 1 (Denosumab 120 mg Q4W)"},{"description":"Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.","id":"FG001","title":"Cohort 2 (Denosumab 120 mg Q4W)"},{"description":"Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.","id":"FG002","title":"Cohort 3 (Denosumab 120 mg Q4W)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"121"},{"groupId":"FG002","numSubjects":"0"}],"type":"Complete Resection (as per protocol)"},{"reasons":[{"groupId":"FG000","numSubjects":"83"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"5"}],"type":"Administrative Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"3"}],"type":"End of Trial"},{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Requirement for Alternative Therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Ineligibility Determined"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"268"},{"groupId":"FG001","numSubjects":"252"},{"groupId":"FG002","numSubjects":"12"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"265"},{"groupId":"FG001","numSubjects":"249"},{"groupId":"FG002","numSubjects":"12"}],"comment":"Received ≥1 dose of denosumab","type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"260"},{"groupId":"FG001","numSubjects":"242"},{"groupId":"FG002","numSubjects":"11"}],"comment":"Eligible for study and received ≥1 dose of denosumab","type":"Efficacy Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Completed the initial treatment phase","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"268"},{"groupId":"FG001","numSubjects":"252"},{"groupId":"FG002","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"3 participants from study 20040215 (NCT00396279) were enrolled directly into safety follow-up phase without retreatment. They were excluded from all defined analysis sets and results are reported for the 532 participants enrolled into the treatment phase. Non-completion reasons are summarized for the on-study period (ie, initial treatment phase).","recruitmentDetails":"Adults and skeletally mature adolescents (≥12 years of age) were enrolled in this open-label single-arm study. The study was conducted at 30 centers in North America, Europe, and Australia from 09 Sep 2008 to study completion on 17 May 2018. The planned study duration for each participant was at least 60 months (following protocol amendment 7)."}