The role and efficacy of denosumab in the treatment of osteoporosis: an update

Bibliography

• Riggs BL, Hodgson SF, O'Fallon WM, Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. N Engl J Med 1990;322:802-9
   PubMed Web of Science ®Google Scholar
• Riggs BL, Parfitt AM. Drugs used to treat osteoporosis: the clinical need for a uniform nomenclature based on their action on bone remodeling. J Bone Miner Res 2005;20:177-88
   PubMed Web of Science ®Google Scholar
• Compston JE, Vedi S, Kaptoge S, Seeman E. Bone remodelling and rate and remodelling balance are not co-regulated in adulthood: implications for the use of activation frequency as an index or remodelling rate. J Bone Miner Res 2007;22:1031-6
   PubMed Web of Science ®Google Scholar
• Seeman E, Delmas PD. Bone quality-the material and structural basis of bone strength and fragility. N Engl J Med 2006;354(21):2250-61
   PubMed Web of Science ®Google Scholar
• Ominsky MS, Vlasseros F, Jolette J, Two doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength. J Bone Miner Res 2010;25(5):948-59
   PubMed Web of Science ®Google Scholar
• Kearns AE, Khosla S, Kostenuik PJ. Receptor activator of nuclear factor kappaB ligand and osteoprotegerin regulation of bone remodeling in health and disease. Endocr Rev 2008;29(2):155-92
   PubMed Web of Science ®Google Scholar
• Lewiecki EM. Treatment of osteoporosis with denosumab. Maturitas 2010;66(2):182-6
   PubMed Web of Science ®Google Scholar
• Miller PD. Denosumab: anti-RANKL antibody. Curr Osteoporos Rep 2009;7:18-22
   PubMedGoogle Scholar
• Bekker PJ, Holloway DL, Rasmussen AS, A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 2004;19:1059-66
   PubMed Web of Science ®Google Scholar
• Lewiecki EM. Denosumab for joints and bone. Curr Rheumatol Rep 2009;11:196-201
   PubMedGoogle Scholar
• Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004;93:2645-68
   PubMed Web of Science ®Google Scholar
• Tang L, Persky AM, Hochhaus G, Meibohm B. Pharmacokinetic aspects of biotechnology products. J Pharm Sci 2004;93:2184-204
   PubMed Web of Science ®Google Scholar
• Geusens P. Emerging treatments for postmenopausal osteoporosis-focus on denosumab. Clin Interv Aging 2009;4:241-50
   PubMed Web of Science ®Google Scholar
• Bekker PJ, Holloway DL, Nakanishi A, The effect of a single dose of osteoprotegerin in postmenopausal women. J Bone Miner Res 2001;16(2):348-60
   PubMed Web of Science ®Google Scholar
• Weiner LM. Fully human therapeutic monoclonal antibodies. J Immunother 2006;29:1-9
   PubMed Web of Science ®Google Scholar
• Lonberg N. Human antibodies from transgenic animals. Nat Biotechnol 2005;23:1117-25
   PubMed Web of Science ®Google Scholar
• McClung MR, Lewiecki EM, Cohen SB, Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006;354:821-31
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ, Warmington K, Grisanti M, RANKL inhibition with AMG 162, a fully human MAb, causes sustained suppression of bone resorption and increased BMD in knockin mice expressing humanized RANKL. J Bone Miner Res 2005;20:S259
   Web of Science ®Google Scholar
• Omnisky MS, Li X, Tan HL, The effects of alendronate or denosumab on cortical and trabecular bone mass, bone strength, and bone mass–strength relationships in mice. J Bone Miner Res 2008;23(Suppl 1):S40
   Google Scholar
• Omnisky MS, Smith SY, Jolette J, Denosumab, a fully human RANKL antibody, reduced bone turnover and increased cancellous and cortical bone mass, density, and strength in ovariectomized cynomolgus monkeys. Calcif Tissue Int 2008;82(Suppl 1):S240
   Google Scholar
• Lewiecki EM, Miller PD, McClung MR, Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res 2007;22:1832-41
   PubMed Web of Science ®Google Scholar
• Miller PD, Bolognese MA, Lewiecki EM, 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 randomised blinded phase 2 clinical trial. Bone 2008;43:222-9
   PubMed Web of Science ®Google Scholar
• Seeman E, Delmas PD, Hanley DA, Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 2010;25(8):1886-94
   PubMed Web of Science ®Google Scholar
• Bone HG, Bolognese MA, Yuen CK, Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 2008;93:2149-57
   PubMed Web of Science ®Google Scholar
• Genant HK, Engelke K, Hanley DA, Denosumab improves density and strength parameters as measured by QCT of the radius in postmenopausal women with low bone mineral density. Bone 2010; In press
   Google Scholar
• Cummings SR, San Martin J, McClung MR, Denosumab for prevention of fractures in postmenopausal women. N Engl J Med 2009;361:756-65
   PubMed Web of Science ®Google Scholar
• Brown JP, Prince RL, Deal C, Comparison of the effect of denosumad and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized blinded, phase 3 trial. J Bone Miner Res 2009;24:153-61
   PubMed Web of Science ®Google Scholar
• Kendler DL, Roux C, Benhamou CL, Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res 2010;25:72-81
   PubMed Web of Science ®Google Scholar
• Kostenuik PJ. Osteoprotegerin and RANKL regulate bone resorption, density, geometry and strength. Curr Opin Pharmacol 2005;5:618-25
   PubMed Web of Science ®Google Scholar
• Garnero P, Sornay-Rendu E, Claustrat B, Biochemical markers of bone turnover, endogenous hormones and the risk of fractures in postmenopausal women: the OFELY study. J Bone Miner Res 2000;15:1526-36
   PubMed Web of Science ®Google Scholar
• Reid I, Benhamou L, Bolognese M, Effects of denosumab on bone histology and histomorphometry: the Freedom and Stand studies. J Bone Miner Res 2009;24(Suppl 1):S9
   Google Scholar
• Geusenns PP, Roux CH, Reid DM, Drug insight: choosing a drug treatment strategy for women with osteoporosis-an evidence-based clinical perspective. Nat Clin Pract Rheumatol 2008;4:240-8
   PubMedGoogle Scholar
• Harris ST, Watts NB, Genant HK, Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999;282:1344-52
   PubMed Web of Science ®Google Scholar
• McClung M, Clemmesen B, Daifotis A, Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Alendronate Osteoporosis Prevention Study Group. Ann Intern Med 1998;128:253-61
   PubMed Web of Science ®Google Scholar
• Delmas PD. Treatment of postmenopausal osteoporosis. Lancet 2002;359:2018-26
   PubMed Web of Science ®Google Scholar
• Bruyere O, Roux C, Detilleux J, Relationship between bone mineral density changes and fracture risk reduction in patients treated with strontium ranelate. J Clin Endocrinol Metab 2007;92:3076-81
   PubMed Web of Science ®Google Scholar
• Collin-Osdoby P. Regulation of vascular calcification by osteoclast regulatory factors RANKL and osteoprotegerin. Circ Res 2004;95:1046-57
   PubMed Web of Science ®Google Scholar
• Beck TJ, Lewiecki EM, Miller PD, Effects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronate. J Clin Densitom 2008;11:351-9
   PubMed Web of Science ®Google Scholar
• Cohen SB, Dore RK, Lane NE, Denosumab treatment effects on structural damage, BMD, and bone turnover in rheumatoid arthritis: a randomized, placebo-controlled clinical trial. Arthritis Rheum 2008;58:1299-309
   PubMed Web of Science ®Google Scholar
• Lipton A, Steger GG, Figueroa J, Active-controlled phase 2 study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol 2007;25:4431-7
   PubMed Web of Science ®Google Scholar
• Anastasilakis AD, Toulis KA, Goulis DG, Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Hom Metab Res 2009;41:721-9
   PubMed Web of Science ®Google Scholar
• Toulis A, Anastasilakis D. Increased risk of serious infections in women with osteopenia or osteoporosis treated with denosumab. Osteoporos Int 2010. [Epub ahead of print]
   Google Scholar
• Henry D, von Moos R, Vadhan-Raj S, A double-blind, randomized study of denosumab versus zolendronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Eur J Cancer Suppl 2009;7(3):9. Joint ECCO 15-34th ESMO Multidisciplinary Congress – Proffered Paper Sessions
   Google Scholar
• Stopeck A, Body JJ, Fujiwara Y, Denosumab versus zolendronic acid for the treatment of breast cancer patients with bone metastases: results of a randomized phase 3 study. Eur J Cancer Suppl 2009;7(3):2-3. Joint ECCO 15-34th ESMO Multidisciplinary Congress – Proffered Paper Sessions
   Web of Science ®Google Scholar
• Cohen SB, Lewiecki EM, Liu Y, Phase 2 study of denosumab (AMG 162) in postmenopausal women: subanalyses and supplemental safety. J Bone Miner Res 2005;20(Suppl 1):S295
   Google Scholar
• Borgstrom F, Kanis JA. Health economics of osteoporosis. Best Pract Res Clin Endocrinol Metab 2008;22:885-90
   PubMed Web of Science ®Google Scholar
• Hiligsmann M, Reginster JY. Potential cost effectiveness of denosumab for the treatment of postmenopausal osteoporotic women. Bone 2010;47(1):34-40
   PubMed Web of Science ®Google Scholar
• Bushardt RL, Turner JL, Ragucci KR, Askins Jr DG. Non-estrogen treatments for osteoporosis: an evidence-based review. JAAPA 2006;19:25-30
   PubMedGoogle Scholar
• Cole Z, Dennison E, Cooper C. Update on the treatment of post-menopausal osteoporosis. Br Med Bull 2008;86:129-43
   PubMed Web of Science ®Google Scholar
• Chesnut CHI, Azria M, Silverman S, Salmon calcitonin: a review of current and future therapeutic indications. Osteoporos Int 2008;19:479-91
   PubMed Web of Science ®Google Scholar
• Stroup J, Kane MP, Abu-Baker A. Teriparatide in the treatment of osteoporosis. Am J Health Syst Pharm 2008;65:532-9
   PubMed Web of Science ®Google Scholar
• Forteo (teriparatide) Package Insert. Indianapolis, IN: Eli Lilly and Co.; 2004
   Google Scholar
• Odvina CV, Zerwekh JE, Rao DS, Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 2005;90:1294-301
   PubMed Web of Science ®Google Scholar
• Lenart BA, Lorich DG, Lane JM. Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med 2008;358:1304-6
   PubMed Web of Science ®Google Scholar
• Kon T, Cho TJ, Aizawa T, Expression of osteoprotegerin, receptor activator of NF-kappaB ligand (osteotegerin ligand) and related proinflammatory cytokines during fracture healing. J Bone Miner Res 2001;16:1004-14
   PubMed Web of Science ®Google Scholar
• Ulrich-Vinther M, Andreassen TT. Osteoprotegerin treatment impairs remodeling and apparent material properties of callus tissue without influencing structural fracture strength. Calcif Tissue Int 2005;76:280-6
   PubMed Web of Science ®Google Scholar
• Flick LM, Weaver JM, Ulrich-Vinther M, Effects of receptor activator of NFkappaB (RANK) signaling blockade on fracture healing. J Orthop Res 2003;21:676-84
   PubMed Web of Science ®Google Scholar
• Gerstenfeld LC, Sacks DJ, Pelis M, Comparison of effects of the bisphosphonate alendronate versus the RANKL inhibitor denosumab on murine fracture healing. J Bone Miner Res 2009;24:196-208
   PubMed Web of Science ®Google Scholar
• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005;353:487-97
   PubMed Web of Science ®Google Scholar
• Kothawala P, Badamgarav E, Ryu S, Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis. Mayo Clin Proc 2007;82:1493-501
   PubMed Web of Science ®Google Scholar
• Reginster JY, Rabenda V, Neuprez A. Adherence, patient preference and dosing frequency: understanding the relationship. Bone 2006;38:S2-6
   PubMed Web of Science ®Google Scholar
• Kendler DL, Bessette L, Hill CD, Preference and satisfaction with a 6-month subcutaneous injection versus a weekly tablet for treatment of low bone mass. Osteoporos Int 2010;21(5):837-46
   PubMed Web of Science ®Google Scholar
• Vanderoost J, Jaecques S, Van der Perre G, Resorption cavity depth explains strength enhancing effect of antiresorptive agents. J Bone Miner Res 2009;24(Suppl 1):S157
   Google Scholar