Denosumab – an emerging treatment for postmenopausal osteoporosis

Bibliography

• Klibanski A, Adams-Campbell L, Bassford T, Osteoporosis prevention, diagnosis, and therapy. JAMA 2001;285(6):785-95
   PubMed Web of Science ®Google Scholar
• Cooper C, Campion G, Melton LJ III. Hip fractures in the elderly: a world-wide projection. Osteoporos Int 1992;2(6):285-9
   PubMed Web of Science ®Google Scholar
• European Foundation for Osteoporosis and Bone Disease National Osteoporosis Foundation. Who are candidates for prevention and treatment for osteoporosis? Osteoporos Int 1997;7(1):1-6
   Web of Science ®Google Scholar
• Melton LJ III, Chrischilles EA, Cooper C, Perspective. How many women have osteoporosis? J Bone Miner Res 1992;7(9):1005-10
   PubMed Web of Science ®Google Scholar
• Center JR, Nguyen TV, Schneider D, Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet 1999;353(9156):878-82
   PubMed Web of Science ®Google Scholar
• Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med 1997;103(2A):12S-9S
   Google Scholar
• World Health Organisation. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Technical Report Series. Geneva, Switzerland, WHO; 1994. p. 1-129
   Google Scholar
• Baim S, Binkley N, Bilezikian JP, Official positions of the International Society for Clinical Densitometry and executive summary of the 2007 ISCD Position Development Conference. J Clin Densitom 2008;11(1):75-91
   PubMed Web of Science ®Google Scholar
• World Health Organization. FRAX WHO Fracture Risk Assessment Tool. 2009. Available from: http://www.shef.ac.uk/FRAX/ [Last accessed 11 January 2010]
   Google Scholar
• Kanis JA, on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health-care level. Technical Report (2007). World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK: Printed by the University of Sheffield
   Google Scholar
• Wainwright SA, Marshall LM, Ensrud KE, Hip fracture in women without osteoporosis. J Clin Endocrinol Metab 2005;90(5):2787-93
   PubMed Web of Science ®Google Scholar
• National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation. Washington, DC; 2008
   Google Scholar
• Kanis JA, Burlet N, Cooper C, European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 2008;19(4):399-428
   PubMed Web of Science ®Google Scholar
• Fujiwara S, Nakamura T, Orimo H, Development and application of a Japanese model of the WHO fracture risk assessment tool (FRAX). Osteoporos Int 2008;19(4):429-35
   PubMed Web of Science ®Google Scholar
• Siminoski K, Leslie WD, Frame H, Recommendations for bone mineral density reporting in Canada: a shift to absolute fracture risk assessment. J Clin Densitom 2007;10(2):120-3
   PubMed Web of Science ®Google Scholar
• Curtis JR, Carbone L, Cheng H, Longitudinal trends in use of bone mass measurement among older Americans, 1999-2005. J Bone Miner Res 2008;23(7):1061-7
   PubMed Web of Science ®Google Scholar
• Foley KA, Foster SA, Meadows ES, Assessment of the clinical management of fragility fractures and implications for the new HEDIS osteoporosis measure. Med Care 2007;45(9):902-6
   PubMed Web of Science ®Google Scholar
• Mccombs JS, Thiebaud P, Laughlin-Miley C, Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48(3):271-87
   PubMed Web of Science ®Google Scholar
• Yood RA, Emani S, Reed JI, Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 2003;14(12):965-8
   PubMed Web of Science ®Google Scholar
• Caro JJ, Ishak KJ, Huybrechts KF, The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004;15(12):1003-8
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services. Bone Health and Osteoporosis: a Report of the Surgeon General. US Department of Health and Human Services, Office of the Surgeon General, Rockville, MD, 2004
   Google Scholar
• Lewiecki EM. RANK ligand inhibition with denosumab for the management of osteoporosis. Expert Opin Biol Ther 2006;6(10):1041-50
   PubMed Web of Science ®Google Scholar
• Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002;288:321-33
   PubMed Web of Science ®Google Scholar
• Anderson GL, Limacher M, Assaf AR, Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291(14):1701-12
   PubMed Web of Science ®Google Scholar
• Liberman UA, Weiss SR, Broll J, Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-43
   PubMed Web of Science ®Google Scholar
• Black DM, Cummings SR, Karpf DB, Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996;348:1535-41
   PubMed Web of Science ®Google Scholar
• Cummings SR, Black DM, Thompson DE, Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures–Results from the fracture intervention trial. JAMA 1998;280(24):2077-82
   PubMed Web of Science ®Google Scholar
• Mcclung MR, Geusens P, Miller PD, Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-40
   PubMed Web of Science ®Google Scholar
• Reginster J-Y, Minne HW, Sorensen OH, Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000;11:83-91
   PubMed Web of Science ®Google 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(14):1344-52
   PubMed Web of Science ®Google Scholar
• Chesnut CH III, Skag A, Christiansen C, Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19(8):1241-9
   PubMed Web of Science ®Google Scholar
• Black DM, Delmas PD, Eastell R, Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356(18):1809-22
   PubMed Web of Science ®Google Scholar
• Lyles KW, Colon-Emeric CS, Magaziner JS, Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007;357(18):1799-809
   PubMed Web of Science ®Google Scholar
• Chesnut CH III, Silverman S, Andriano K, A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am J Med 2000;109(4):267-76
   PubMed Web of Science ®Google Scholar
• Reginster JY, Seeman E, De Vernejoul MC, Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study. J Clin Endocrinol Metab 2005;90(5):2816-22
   PubMed Web of Science ®Google Scholar
• Meunier PJ, Roux C, Seeman E, The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med 2004;350(5):459-68
   PubMed Web of Science ®Google Scholar
• Ettinger B, Black DM, Mitlak BH, Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene–Results from a 3-year randomized clinical trial. JAMA 1999;282(7):637-45
   PubMed Web of Science ®Google Scholar
• Silverman SL, Christiansen C, Genant HK, Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res 2008;23(12):1923-34
   PubMed Web of Science ®Google Scholar
• Cummings SR, Eastell R, Ensrud K, The effects of lasofoxifene on fractures and breast cancer: 3-year results from the PEARL trial. J Bone Miner Res 2008;23(Suppl 1):S81
   Google Scholar
• Neer RM, Arnaud CD, Zanchetta JR, Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001;344:1434-41
   PubMed Web of Science ®Google Scholar
• Greenspan SL, Bone HG, Ettinger MP, Effect of recombinant human parathyroid hormone (1 – 84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med 2007;146(5):326-39
   PubMed Web of Science ®Google Scholar
• Ettinger B, Pressman A, Schein J. Clinic visits and hospital admissions for care of acid-related upper gastrointestinal disorders in women using alendronate for osteoporosis. Am J Man Care 1998;4:1377-82
   PubMed Web of Science ®Google 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(7):1059-66
   PubMed Web of Science ®Google Scholar
• Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004;93(11):2645-68
   PubMed Web of Science ®Google Scholar
• Tang L, Persky AM, Hochhaus G, Pharmacokinetic aspects of biotechnology products. J Pharm Sci 2004;93(9):2184-204
   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(8):821-31
   PubMed Web of Science ®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 bone mineral density. 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 randomized blinded phase 2 clinical trial. Bone 2008;43(2):222-9
   PubMed Web of Science ®Google Scholar
• Gallagher JC, Rapuri PB, Haynatzki G, Effect of discontinuation of estrogen, calcitriol, and the combination of both on bone density and bone markers. J Clin Endocrinol Metab 2002;87(11):4914-23
   PubMed Web of Science ®Google Scholar
• Miller P, Bolognese M, Lewiecki E, Effects of denosumab on bone mineral density and biochemical markers of bone turnover: 6 year results of a phase 2 clinical trial. 2009. Available from: http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=1cf516b5-29be-4edf-b1ed-7fa92b4f2031 [Last accessed 11 January 2010]
   Google Scholar
• Cummings SR, San Martin J, Mcclung MR, Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361(8):756-65
   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(6):2149-57
   PubMed Web of Science ®Google Scholar
• Brown JP, Prince RL, Deal C, Comparison of the effect of denosumab 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(1):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 2009: published online 13 July 2009, doi:10.1359/jbmr.090716
   Google Scholar
• Clowes JA, Riggs BL, Khosla S. The role of the immune system in the pathophysiology of osteoporosis. Immunol Rev 2005;208:207-27
   PubMed Web of Science ®Google Scholar
• Xing L, Schwarz EM, Boyce BF. Osteoclast precursors, RANKL/RANK, and immunology. Immunol Rev 2005;208:19-29
   PubMed Web of Science ®Google Scholar
• Dougall WC, Glaccum M, Charrier K, RANK is essential for osteoclast and lymph node development. Genes Dev 1999;13(18):2412-24
   PubMed Web of Science ®Google Scholar
• Kong YY, Yoshida H, Sarosi I, OPGL is a key regulator of osteoclastogenesis, lymphocyte development and lymph-node organogenesis. Nature 1999;397(6717):315-23
   PubMed Web of Science ®Google Scholar
• Stolina M, Dwyer D, Ominsky MS, Continuous RANKL inhibition in osteoprotegerin transgenic mice and rats suppresses bone resorption without impairing lymphorganogenesis or functional immune responses. J Immunol 2007;179(11):7497-505
   PubMed Web of Science ®Google Scholar
• Stolina M, Dwyer D, Morony S, Rats and mice overexpressing soluble OPG have high bone mass but no alteration in immunological parameters or lymphocyte function. Arthritis Rheum 2005;20:S708
   Google Scholar
• Reid I, Benhamou CL, Bolognese M, Effects of denosumab on bone histology and histomorphometry: the FREEDOM and STAND studies. 2009. Available from: http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx? aid=1778e37e-cc4c-482c-a20d-6ae66570d65d [Last accessed 11 January 2010]
   Google Scholar
• Briefing Information for the August 13, 2009 Meeting of the Reproductive Health Drugs Advisory Committee. Washington, DC: United States Food And Drug Administration, Amgen Inc.2009. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ ReproductiveHealthDrugsAdvisoryCommittee/ucm176584.htm [Last accessed 11 January 2010]
   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. Horm Metab Res 2009;41(10):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 2009: published online15 December 2009, doi:10.1007/s00198-009-1145-1
   Google Scholar
• Ellis GK, Bone HG, Chlebowski R, Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008;26(30):4875-82
   PubMed Web of Science ®Google Scholar
• Smith MR, Egerdie B, Hernandez TN, Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med 2009;361(8):745-55
   PubMed Web of Science ®Google Scholar
• Fizazi K, Lipton A, Mariette X, 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
   PubMed Web of Science ®Google Scholar
• Lewiecki Em NB. Assessing response to osteoporosis therapy. Osteoporos Int 2008;19(10):1363-8
   PubMed Web of Science ®Google Scholar