{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"}]}],"title":"Skeletal events overall"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Pathological fracture"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Initiation of radiotherapy or surgery on bone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Spinal cord compression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Hypercalcemia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"69"}],"units":"Participants"}],"description":"* Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline\n* Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography\n* Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression\n* Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression\n* Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl","groups":[{"description":"Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.","id":"OG000","title":"Zoledronic Acid (ZOL446)"},{"description":"No Treatment with study medication.","id":"OG001","title":"Control"}],"paramType":"NUMBER","populationDescription":"Intent to treat population","reportingStatus":"POSTED","timeFrame":"48 months","title":"The Number of Participants With the Development of Skeletal Complications","type":"SECONDARY","unitOfMeasure":"Participants"}