American Cancer Society. Bone metastasis. American Cancer Society website. http://www.cancer.org/acs/groups/cid/documents/webcontent/003087-pdf.pdf. Revised February 17, 2014. Accessed June 1, 2015.
Bekker PJ, Holloway DL, Rasmussen AS, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004;19:1059-1066.
Ben-Josef E, Shamsa F, Williams AO, Porter AT. Radiotherapeutic management of osseous metastases: a survey of current patterns of care. Int J Radiat Oncol Biol Phys. 1998;40:915-921.
Brodowicz T, O’Byrne K, Manegold C. Bone matters in lung cancer. Ann Oncol. 2012;23:2215-2222.
Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(suppl 20):6243s-6249s.
Data on file, Amgen.
Di Leo A, Gomez HL, Aziz Z, et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol. 2008;26:5544-5552.
FDA news release. FDA approves Xgeva to treat giant cell tumor of the bone. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm356528.htm. Accessed January 27, 2016.
FDA supplemental approval. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf. Accessed January 27, 2016.
Fizazi K, Brown JE, Carducci M, et al. Denosumab in patients with metastatic prostate cancer previously treated with denosumab or zoledronic acid: 2-year open-label extension phase results from the pivotal phase 3 study. Poster presented at: 37th Annual European Society for Medical Oncology Congress; September 28-October 2, 2012; Vienna, Austria. Abstract 937P.
Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377:813-822.
Garcia RA, Inwards CY, Unni KK. Benign bone tumors—recent developments. Semin Diagn Pathol. 2011;28:73-85.
Gastanaga V, Jain R, Pirolli M, et al. Prevalence of hypercalcemia of malignancy in the United States. Poster presented at: American Society for Bone and Mineral Research Annual Meeting; October 4-7, 2013; Baltimore, MD.
Gralow JR, Biermann JS, Farooki A, et al. NCCN Task Force report: bone health in cancer care. J Natl Compr Canc Netw. 2013;11(suppl 3):s1-s50.
Grill V, Martin TJ. Hypercalcemia of malignancy. Rev Endocr Metab Disord. 2000;1:253-263.
Henry D, Vadhan-Raj S, Hirsh V, et al. Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors. Support Care Cancer. 2014;22:679-687.
Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29:1125-1132.
Hu MI, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab. 2014;99:3144-3152.
Hussain A, Abdulhalim AM, Mullins CD, et al. Prevalence of first and subsequent skeletal-related events (SREs) in U.S. elderly patients with metastatic prostate cancer (mPC). J Clin Oncol. 2014;32(suppl 15):abstract e16006.
Ibrahim A, Scher N, Williams G, et al. Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. Clin Cancer Res. 2003;9:2394-2399.
Kantoff PW, Higano CS, Shore ND, et al; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
Keizer RJ, Huitema ADR, Schellens JHM, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:493-507.
Kelly WK, Halabi S, Carducci M, et al. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol. 2012;30:1534-1540.
Kim Y, Nizami S, Goto H, Lee FY. Modern interpretation of giant cell tumor of bone: predominantly osteoclastogenic stromal tumor. Clin Orthop Surg. 2012;4:107-116.
Levack P, Graham J, Collie D, et al; The Scottish Cord Compression Study Group. Don’t wait for a sensory level—listen to the symptoms: a prospective audit of the delays in diagnosis of malignant cord compression. Clin Oncol (R Coll Radiol). 2002:14:472-480.
Lewiecki EM. Denosumab: an investigational drug for the management of postmenopausal osteoporosis. Biologics. 2008;2:645-653.
Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48:3082-3092.
Lipton A, Theriault RL, Hortobagyi GN, et al. Pamidtonate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000;88:1082-1090.
Lutz ST, Chow EL, Hartsell WF, Konski AA. A review of hypofractionated palliative radiotherapy. Cancer. 2007;109:1462-1470.
Major P, Lortholary A, Hon J, et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol. 2001;19:558-567.
MedlinePlus. Calcium blood test. National Institutes of Health website. http://www.nlm.nih.gov/medlineplus/ency/article/003477.htm. Updated September 29, 2013. Accessed October 21, 2015.
MedlinePlus. Hypocalcemia-infants. National Institutes of Health website. http://www.nlm.nih.gov/medlineplus/ency/article/007229.htm. Updated December 14, 2013. Accessed October 21, 2015.
Mendenhall WM, Zlotecki RA, Scarborough MT, Gibbs CP, Mendenhall NP. Giant cell tumor of bone. Am J Clin Oncol. 2006;29:96-99.
Mercadante S. Malignant bone pain: pathophysiology and treatment. Pain. 1997;69:1-18.
Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357:2666-2676.
Moore RE, Lackman RD. Metastatic bone disease. UPOJ. 2010;20:117-120.
Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs. 2010;24:23-39.
Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2:584-593.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, Version 3.2015. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#breast. Published July 16, 2015. Accessed November 10, 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 1.2015. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#prostate. Published October 24, 2014. Accessed November 10, 2015.
Nielsen OS, Munro AJ, Tannock IF. Bone metastases: pathophysiology and management policy. J Clin Oncol. 1991;9:509-524.
Osborn JL, Getzenberg RH, Trump DL. Spinal cord compression in prostate cancer. J Neurooncol. 1995;23:135-147.
Ralston SH, Gallacher SJ, Patel U, et al. Cancer-associated hypercalcemia: morbidity and mortality. Ann Intern Med. 1990;112:499-504.
Reid R, Banerjee SS, Sciot R. Giant cell tumour. In: Fletcher CDM, Unni KK, Mertens F, eds. World Health Organization Classification of Tumours: Pathology and Genetics of Tumours of Soft Tissue and Bone. Lyon, France: IARC Press; 2002:309-313.
Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664.
Rosen LS, Gordon D, Tchekmedyian NS, et al; on behalf of the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004;100:2613-2621.
Saad F, Eastham J. Zoledronic acid improves clinical outcomes when administered before onset of bone pain in patients with prostate cancer. Urology. 2010;76:1175-1181.
Saad F, Gleason DM, Murray R, et al; Zoledronic Acid Prostate Cancer Study Group. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst. 2002;94:1458-1468.
Saad F, Gleason DM, Murray R, et al; Zoledronic Acid Prostate Cancer Study Group. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004;96:879-882.
Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of US Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis. 2011:14:177-183.
Stewart AF. Hypercalcemia associated with cancer. N Engl J Med. 2005;352:373-379.
Stopeck AT, Fizazi K, Body JJ, et al. Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer. Support Care Cancer. 2016;24:447-455.
Stopeck AT, Lipton A, Body J-J, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28:5132-5139.
Sutjandra L, Rodriguez RD, Doshi S, et al. Population pharmacokinetic meta-analysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosis. Clin Pharmacokinet. 2011;50:793-807.
Swain SM, Kim S-B, Cortés J, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013;14:461-471.
Tannock IF, Fizazi K, Ivanov S, et al; VENICE investigators. Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial. Lancet Oncol. 2013;14:760-768.
Thomas DM, Skubitz KM. Giant cell tumour of bone. Curr Opin Oncol. 2009;21:338-344.
Torbert JT, Lackman RD. Pathologic fractures. In: Pignolo RJ, Keenan MA, Hebela NM, eds. Fractures in the Elderly: A Guide to Practical Management. 1st ed. New York, NY: Springer Science and Business Media; 2011:43-53.
Turcotte RE. Giant cell tumor of bone. Orthop Clin North Am. 2006;37:35-51.
Wedin R. Surgical treatment for pathologic fracture. Acta Orthop Scand Suppl. 2001;72(suppl 302):1-29.
XGEVA® (denosumab) prescribing information, Amgen.
Zhu Y-J. Palliative radiotherapy for painful bone metastases: short-course or long-course? Ann Palliat Med. 2012;1:78-80.