Reduced Dose-density of Denosumab for Unresectable GCTB

You may not qualify if:

• Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
• Concurrent bisphosphonate treatment and calcitonin
• Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
• Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
• Creatinine clearance \< 30 mL/min
• Hemoglobin \< 10.0 g/dL or 6.2 mmol/L
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
• Active dental or jaw condition which requires oral surgery, including tooth extraction
• Non-healed dental/oral surgery
• Planned invasive dental procedure for the course of the study
• Known hypersensitivity to the active substance or to any of the excipients (glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20)
• Treatment with other investigational device or drug 30 days prior to registration
• Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
• Unstable systemic disease including active and uncontrolled infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before registration
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.