Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Inclusion criteria: * Pathologically confirmed GCTB within 1 year before study enrollment * Measurable evidence of active disease within 1 year before study enrollment * Subjects with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity * Karnofsky performance status equal or greater than 50% (ie, Eastern Cooperative Oncology Group status 0, 1, or 2) * Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) equal or greater than 12 years of age * Skeletally mature adolescents must weigh at least 45 kg * Before any study-specific procedure is performed, the appropriate written informed consent must be obtained Exclusion criteria: * Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization) * Concurrent bisphosphonate treatment * Known or suspected current diagnosis of underlying malignancy including high grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma * Known or suspected current diagnosis of non GCTB giant cell-rich tumors * Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease * Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carci…