Denosumab: A novel antiresorptive drug for osteoporosis

Cleveland Clinic Journal of Medicine

Volumn 82, Issue 2, 2015, Pages 105-114

  Suresh, Ernest ^a   Abrahamsen, Bo ^b,c  

^a Alexandra Hospital (Jurong Health)   (Singapore)

^b UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^c GLOSTRUP UNIVERSITY HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

BONE DENSITY CONSERVATION AGENT; DENOSUMAB; MONOCLONAL ANTIBODY; OSTEOCLAST DIFFERENTIATION FACTOR;

AGED; ANTAGONISTS AND INHIBITORS; BONE DENSITY; CASE REPORT; COMPLICATION; DRUG EFFECTS; FEMALE; HUMAN; INJURIES; LUMBAR VERTEBRA; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; PHOTON ABSORPTIOMETRY; RADIOGRAPHY; SPINAL FRACTURES; VERTEBRA;

ABSORPTIOMETRY, PHOTON; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; FEMALE; HUMANS; LUMBAR VERTEBRAE; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; RANK LIGAND; SPINAL FRACTURES; THORACIC VERTEBRAE;

EID: 84924072215     PISSN: 08911150     EISSN: None     Source Type: Journal    
DOI: 10.3949/ccjm.82a.13173     Document Type: Article

References (72)

1. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006; 17:1726-1733.
2. Gullberg B, Johnell O, Kanis JA. World-wide projections for hip fracture. Osteoporos Int 1997; 7:407-413.
3. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007; 22:465-475.
4. Melton LJ 3rd, Chrischilles EA, Cooper C, Lane AW, Riggs BL. Perspective. How many women have osteoporosis? J Bone Miner Res 1992; 7:1005-1010.
5. Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int 2009; 20:1633-1650.
6. Jalava T, Sarna S, Pylkkänen L, et al. Association between vertebral fracture and increased mortality in osteoporotic patients. J Bone Miner Res 2003; 18:1254-1260.
7. Ismail AA, O'Neill TW, Cooper C, et al. Mortality associated with vertebral deformity in men and women: results from the European Prospective Osteoporosis Study (EPOS). Osteoporos Int 1998; 8:291-297.
8. Ensrud KE, Thompson DE, Cauley JA, et al. Prevalent vertebral deformities predict mortality and hospitalization in older women with low bone mass. Fracture Intervention Trial Research Group. J Am Geriatr Soc 2000; 48:241-249.
9. Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med 1999; 159:1215-1220.
10. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001; 285:320-323.
11. Ross PD, Davis JW, Epstein RS, Wasnich RD. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 1991; 114:919-923.
12. Piscitelli P, Iolascon G, Argentiero A, et al. Incidence and costs of hip fractures vs strokes and acute myocardial infarction in Italy: comparative analysis based on national hospitalization records. Clin Interv Aging 2012; 7:575-583.
13. Johnell O, Kanis JA, Jonsson B, Oden A, Johansson H, De Laet C. The burden of hospitalised fractures in Sweden. Osteoporos Int 2005; 16:222-228.
14. Confavreux CB, Canoui-Poitrine F, Schott AM, Ambrosi V, Tainturier V, Chapurlat RD. Persistence at 1 year of oral antiosteoporotic drugs: a prospective study in a comprehensive health insurance database. Eur J Endocrinol 2012; 166:735-741.
15. Biswas PN, Wilton LV, Shakir SA. Pharmacovigilance study of alendronate in England. Osteoporos Int 2003; 14:507-514.
16. Landfeldt E, Ström O, Robbins S, Borgström F. Adherence to treatment of primary osteoporosis and its association to fractures-the Swedish Adherence Register Analysis (SARA). Osteoporos Int 2012; 23:433-443.
17. Sampalis JS, Adachi JD, Rampakakis E, Vaillancourt J, Karellis A, Kindundu C. Long-term impact of adherence to oral bisphospho nates on osteoporotic fracture incidence. J Bone Miner Res 2012; 27:202-210.
18. Schwarz EM, Ritchlin CT. Clinical development of anti-RANKL therapy. Arthritis Res Ther 2007; 9(suppl 1):S7.
19. Hanley DA, Adachi JD, Bell A, Brown V. Denosumab: mechanism of action and clinical outcomes. Int J Clin Pract 2012; 66:1139-1146.
20. Bekker PJ, Holloway D, Nakanishi A, Arrighi M, Leese PT, Dunstan CR. The effect of a single dose of osteoprotegerin in postmenopausal women. J Bone Miner Res 2001; 16:348-360.
21. Rizzoli R, Body JJ, Brandi ML, et al; International Osteoporosis Foundation Committee of Scientific Advisors Working Group on Cancer- Induced Bone Disease. Cancer-associated bone disease. Osteoporos Int 2013; 24:2929-2953.
22. Schwarz P, Rasmussen AQ, Kvist TM, Andersen UB, Jørgensen NR. Paget's disease of the bone after treatment with denosumab: a case report. Bone 2012; 50:1023-1025.
23. Hu MI, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab 2014; Jun 10 [Epub ahead of print].
24. Cummings SR, San Martin J, McClung MR, et al; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009; 361:756-765.
25. Papapoulos S, Lippuner K, Roux C, et al. Eight years of denosumab treatment in postmenopausal women with osteoporosis: results from the first five years of the FREEDOM extension [abstract]. Presented at the 2013 annual meeting of the American Society for Bone and Mineral Research, Baltimore, MD, October 4-7, 2013.
26. Bone HG, Chapurlat R, Brandi ML, et al. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab 2013; 98:4483-4492.
27. McClung MR, Boonen S, Törring O, et al. Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis. J Bone Miner Res 2012; 27:211-218.
28. Boonen S, Adachi JD, Man Z, et al. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 2011; 96:1727-1736.
29. McCloskey EV, Johansson H, Oden A, et al. Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res 2012; 27:1480-1486.
30. McClung MR, Lewiecki EM, Geller ML, et al. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial. Osteoporos Int 2013; 24:227-235.
31. McClung MR, Lewiecki EM, Cohen SB, et al; AMG 162 Bone Loss Study Group. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006; 354:821-831.
32. Bone HG, Bolognese MA, Yuen CK, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 2008; 93:2149-2157.
33. Genant HK, Engelke K, Hanley DA, et al. Denosumab improves density and strength parameters as measured by QCT of the radius in postmenopausal women with low bone mineral density. Bone 2010; 47:131-139.
34. Orwoll E, Teglbjærg CS, Langdahl BL, et al. A randomized, placebocontrolled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab 2012; 97:3161-3169.
35. Tsai JN, Uihlein AV, Lee H, et al. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet 2013; 382:50-56.
36. Smith MR, Egerdie B, Hernández Toriz N, et al; Denosumab HALT Prostate Cancer Study Group. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med 2009; 361:745-755.
37. Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008; 26:4875-4882.
38. Brown JP, Prince RL, Deal C, et al. 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; 24:153-161.
39. Kendler DL, Roux C, Benhamou CL, et al. 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.
40. Seeman E, Delmas PD, Hanley DA, et al. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 2010; 25:1886-1894.
41. Hopkins RB, Goeree R, Pullenayegum E, et al. The relative efficacy of nine osteoporosis medications for reducing the rate of fractures in post-menopausal women. BMC Musculoskelet Disord 2011; 12:209.
42. National Institute for Health and Care Excellence (NICE). NICE technology appraisal guidance: TA161. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (amended). http://publications.nice.org.uk/ alendronate-etidronate-risedronate-raloxifene-strontium-ranelateand- teriparatide-for-ta161. Accessed January 9, 2015.
43. Freemantle N, Satram-Hoang S, Tang ET, et al; DAPS Investigators. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int 2012; 23:317-326.
44. Lewiecki EM. Safety and tolerability of denosumab for the treatment of postmenopausal osteoporosis. Drug Healthc Patient Saf 2011; 3:79-91.
45. Watts NB, Roux C, Modlin JF, et al. Infections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association? Osteoporos Int 2012; 23:327-337.
46. von Keyserlingk C, Hopkins R, Anastasilakis A, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum 2011; 41:178-186.
47. Geller M, Wagman RB, Ho PR, et al. Early findings from Prolia postmarketing safety surveillance for atypical femoral fracture, osteonecrosis of the jaw, severe symptomatic hypocalcemia, and anaphylaxis (abstract). Osteoporos Int 2014; 25(suppl 2). OC40; www.wco-iof-esceo.org/sites/ecceo14/docs/wco14-abstractbook.pdf. Accessed January 9, 2015.
48. McCormick BB, Davis J, Burns KD. Severe hypocalcemia following denosumab injection in a hemodialysis patient. Am J Kidney Dis 2012; 60:626-628.
49. Jamal SA, Ljunggren O, Stehman-Breen C, et al. Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res 2011; 26:1829-1835.
50. Block GA, Bone HG, Fang L, Lee E, Padhi D. A single-dose study of denosumab in patients with various degrees of renal impairment. J Bone Miner Res 2012; 27:1471-1479.
51. Ungprasert P, Cheungpasitporn W, Srivali N, Kittanamongkolchai W, Bischof EF. Life-threatening hypocalcemia associated with denosumab in a patient with moderate renal insufficiency. Am J Emerg Med 2013; 31:756.e1-e2.
52. McCormick BB, Davis J, Burns KD. Severe hypocalcemia following denosumab injection in a hemodialysis patient. Am J Kidney Dis 2012; 60:626-628.
53. Rachner TD, Platzbecker U, Felsenberg D, Hofbauer LC. Osteonecrosis of the jaw after osteoporosis therapy with denosumab following long-term bisphosphonate therapy. Mayo Clin Proc 2013; 88:418-419.
54. Epstein MS, Ephros HD, Epstein JB. Review of current literature and implications of RANKL inhibitors for oral health care providers. Oral Surg Oral Med Oral Pathol Oral Radiol 2013; 116:e437-e442.
55. McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med 2013; 126:13-20.
56. Baron R, Ferrari S, Russell RG. Denosumab and bisphosphonates: different mechanisms of action and effects. Bone 2011; 48:677-692.
57. 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.
58. Miller PD, Bolognese MA, Lewiecki EM, et al; Amg Bone Loss Study Group. 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; 43:222-229.
59. Parthan A, Kruse M, Yurgin N, Huang J, Viswanathan HN, Taylor D. Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US. Appl Health Econ Health Policy 2013; 11:485-497.
60. Scotland G, Waugh N, Royle P, McNamee P, Henderson R, Hollick R. Denosumab for the prevention of osteoporotic fractures in postmenopausal women: a NICE single technology appraisal. Pharmacoeconomics 2011; 29:951-961.
61. Jönsson B, Ström O, Eisman JA, et al. Cost-effectiveness of denosumab for the treatment of postmenopausal osteoporosis. Osteoporos Int 2011; 22:967-982.
62. Clinician's guide to prevention and treatment of osteoporosis. Washington DC: National Osteoporosis Foundation, 2013.
63. Watts NB, Bilezikian JP, Camacho PM, et al; AACE Osteoporosis Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract 2010;16(suppl 3):1-37.
64. Papaioannou A, Morin S, Cheung AM, et al; Scientific Advisory Council of Osteoporosis Canada. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ 2010; 182:1864-1673.
65. National Institute for Health and Care Excellence (NICE). NICE technology appraisal: TA204. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. http://guidance. nice.org.uk/TA204. Accessed January 9, 2015.
66. Premaor MO, Compston JE. Testing for secondary causes of osteoporosis. BMJ 2010; 341:c6959.
67. Hochberg MC, Ross PD, Black D, et al. Larger increases in bone mineral density during alendronate therapy are associated with a lower risk of new vertebral fractures in women with postmenopausal osteoporosis. Fracture Intervention Trial Research Group. Arthritis Rheum 1999; 42:1246-1254.
68. Eastell R, Vrijens B, Cahall DL, Ringe JD, Garnero P, Watts NB. Bone turnover markers and bone mineral density response with risedronate therapy: relationship with fracture risk and patient adherence. J Bone Miner Res 2011; 26:1662-1669.
69. Diez-Perez A, Adachi JD, Agnusdei D, et al; IOF CSA Inadequate Responders Working Group. Treatment failure in osteoporosis. Osteoporos Int 2012; 23:2769-2774.
70. Eastell R, Barton I, Hannon RA, Chines A, Garnero P, Delmas PD. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res 2003; 18:1051-1056.
71. Rosen HN, Moses AC, Garber J, Ross DS, Lee SL, Greenspan SL. Utility of biochemical markers of bone turnover in the follow-up of patients treated with bisphosphonates. Calcif Tissue Int 1998; 63:363-368.
72. Bolognese MA, Teglbjærg CS, Zanchetta JR, et al. Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study. J Clin Densitom 2013; 16:147-153.