Study of Denosumab in Subjects With Giant Cell Tumor of Bone

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 carcinoma and cervical carcinoma in situ are permitted)
• •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
• •Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
• •Subject has known sensitivity to any of the products to be administered during dosing
• •Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
• •Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
• •Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
• •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures