Clinical trials in osteoporosis

Bekker PJ. 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(7):1059-66.

McClung MR. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006;354(8):821-31.

Lewiecki EM. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res 2007;22(12):1832-41.

Miller PD. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone 2008;43(2):222-9.

Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 2008;93(6):2149-57.

Beck TJ. Effects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronate. J Clin Densitom 2008;11(3):351-9.

Cummings SR. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361(8):756-65.

Kendler DL. Effects of Denosumab on Bone Mineral Density and Bone Turnover in Postmenopausal Women Transitioning from Alendronate Therapy. J Bone Miner Res 2009.

Brown JP. Comparison of the Effect of Denosumab and Alendronate on Bone Mineral Density and Biochemical Markers of Bone Turnover in Postmenopausal Women With Low Bone Mass: A Randomized, Blinded, Phase 3 Trial. J Bone Miner Res 2009:1-34.

Genant HK. Denosumab improves density and strength parameters as measured by QCT of the radius in postmenopausal women with low bone mineral density. Bone 2010;47(1):131-9.

Reid I. Effects of denosumab on bone histomorphometry: The freedom and stand studies. J Bone Miner Res 2010.

Men with non-metastatic prostate cancer treated with androgen deprivation

Smith MR. Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. J Urol 2009;182(6):2670-5.

Smith MR. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med 2009;361(8):745-55.

Women with non-metastatic breast cancer and aromatase inhibition

Ellis GK. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008;26(30):4875-82.

Rheumatoid Arthritis

Cohen SB. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum 2008;58(5):1299-309.

Deodhar A. Denosumab-mediated increase in hand bone mineral density associated with decreased progression of bone erosion in rheumatoid arthritis patients. Arthritis Care Res (Hoboken) 2010;62(4):569-74.

Dore RK. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis 2010;69(5):872-5.

Sharp JT. Denosumab prevents metacarpal shaft cortical bone loss in patients with erosive rheumatoid arthritis. Arthritis Care Res (Hoboken) 2010;62(4):537-44.

Metastatic cancer

Body JJ. A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer. Clin Cancer Res 2006;12(4):1221-8.

Lipton A. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res 2008;14(20):6690-6.

Fizazi K. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol 2009;182(2):509-15; discussion 15-6.

Fizazi K. Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol 2009;27(10):1564-71.

Vij R. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol 2009;84(10):650-6.

Kyrgidis A. Safety and efficacy of denosumab in giant-cell tumour of bone. Lancet Oncol 2010;11(6):513-4.

Nanes MS. Preventing metastases to bone: denosumab or bisphosphonates? J Bone Miner Res 2010;25(3):437-9.

Thomas D. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol 2010;11(3):275-80.

Body JJ. Effects of denosumab in patients with bone metastases with and without previous bisphosphonate exposure. J Bone Miner Res 2010;25(3):440-6.

Updated 7/4/10