Zoledronic acid

Expert Opinion on Drug Safety

Volumn 10, Issue 1, 2011, Pages 133-145

  Coleman, Robert ^a   Burkinshaw, Roger ^a   Winter, Matthew ^a   Neville Webbe, Helen ^b   Lester, Jim ^a   Woodward, Emma ^a,c   Brown, Janet ^a,c  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b CLATTERBRIDGE CENTRE FOR ONCOLOGY   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

acute phase response; atypical fractures; bisphosphonates; osteonecrosis of the jaw; renal safety; side effects; zoledronic acid

Indexed keywords

CALCIUM; CREATININE; VITAMIN D; ZOLEDRONIC ACID;

ANTIBIOTIC THERAPY; ARTHRALGIA; ARTICLE; BONE METASTASIS; CONJUNCTIVITIS; CREATININE BLOOD LEVEL; DEBRIDEMENT; DISEASE CLASSIFICATION; DRUG BINDING; DRUG EXCRETION; DRUG FEVER; DRUG METABOLISM; DRUG SAFETY; DRUG UPTAKE; EPISCLERITIS; HEART ATRIUM FIBRILLATION; HUMAN; HYPERCALCEMIA; HYPOCALCEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; JAW OSTEONECROSIS; MYALGIA; NEPHROTOXICITY; NONHUMAN; OSTEOCLAST; OSTEOPOROSIS; PAGET BONE DISEASE; PARESTHESIA; PATHOLOGIC FRACTURE; PERIORBITAL EDEMA; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SCLERITIS; SKIN ALLERGY; STRESS FRACTURE; TERATOGENICITY; TETANY; UVEITIS; VITAMIN SUPPLEMENTATION;

BONE DENSITY CONSERVATION AGENTS; BONE DISEASES; DIPHOSPHONATES; DRUG TOXICITY; FRACTURES, BONE; HUMANS; IMIDAZOLES;

EID: 78650484766     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.2011.540387     Document Type: Article

References (107)

1. Coleman RE. Risks and benefits of bisphosphonates. Br J Cancer 2008;98(11):1736-40
2. Neville-Webbe HL, Coleman RE. Bisphosphonates and RANK ligand inhibitors for the treatment and prevention of metastatic bone disease. Eur J Cancer 2010;46:1211-22
3. Coleman RE, Body J-J, Gralow JR, Lipton A. Bone loss in patients with breast cancer receiving aromatase inhibitors and associated treatment strategies. Cancer Treat Rev 2008;34(Suppl 1):S31-42
4. Holen I, Coleman RE. Bisphosphonates as treatment of bone metastases. Curr Pharm Des 2010;16:1262-71
5. Dieli F, Vermijlen D, Fulfaro F, et al. Targeting human gammadeltaT cells with zoledronate and interleukin-2 for immunotherapy of hormone-refractory prostate cancer. Cancer Res 2007;67:7450-7 (Pubitemid 47206575)
6. Pfister T, Atzpodien E, Bohrmann B, Bauss F. Acute renal effects of intravenous bisphosphonates in the rat. Basic Clin Pharmacol Toxicol 2005;97(6):374-81 (Pubitemid 43028785)
7. Fleisch H. Bisphosphonates: mechanisms of action. Endocr Rev 1998;19(1):80-100 (Pubitemid 29122075)
8. Chaudhary M, Tamta A, Sehgal R. Evaluation of toxicity profile of zoledronic acid in Wistar rat; a sub-chronic toxicity study. Internet J Toxicol 2009;6(2)
9. Pfister T, Atzpodien E, Bauss F. The renal effects of minimally nephrotoxic doses of ibandronate and zoledronate following single and intermittent intravenous administration in rats. Toxicology 2003;191(2-3):159-67 (Pubitemid 37329461)
10. Luhe A, Kunkele KP, Haiker M, et al. Preclinical evidence for nitrogen-containing bisphosphonate inhibition of farnesyl diphosphate (FPP) synthase in the kidney: implications for renal safety. Toxicol In Vitro 2008;22(4):899-909
11. Levy S, Fayez I, Taguchi N, et al. Pregnancy outcome following in utero exposure to bisphosphonates. Bone 2009;44(3):428-30
12. Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol 2005;23:3314-21 (Pubitemid 46243475)
13. Rosen LS, Gordon D, Kaminski M, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in thetreatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma. Cancer 2003;98:1735-44
14. Black D, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356:1809-22 (Pubitemid 46698462)
15. Boonen S, Black DM, Colon-Emeric CS, et al. Efficacy and safety of a once-yearly intravenous zoledronic acid 5 mg for fracture prevention in elderly. Postmenopausal Women with Osteoporosis Aged 75 and Older. J Am Geriatr Soc 2010;58:292-9
16. Reid I, Brown J, Burckhardt P, et al. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med 2002;346:653-66 (Pubitemid 38811329)
17. Kunzmann V, Bauer E, Feurle J, et al. Stimulation of gammadeltaT cells by aminobisphosphonates and induction of antiplasma cell activity in multiple myeloma. Blood 2000;96:384-92 (Pubitemid 30463353)
18. Gober HJ, Kitstowska M, Angman L, et al. Human T cell receptor gamma delta cells recognize endogenous mevalonate metabolites in tumour cells. J Exp Med 2002;197:163-8 (Pubitemid 36152311)
19. Musto P, Petrucci MT, Bringhen S, et al. A multicenter, randomized clinical trial comparing zoledronic acid versus observation in patients with asymptomatic myeloma. Cancer 2008;113(7):1588-95
20. Carteni G, Bordonaro R, Giotta F, et al. Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone: a Multicenter Clinical Trial. Oncologist 2006;11(7):841-8 (Pubitemid 44157572)
21. Peter R, Mishra V, Fraser WD. Severe hypocalcaemia after being given intravenous bisphosphonate. Br Med J 2004;328(7435):335-6 (Pubitemid 38789208)
22. Singh D, Khaira NS, Sekhon JS. Symptomatic hypocalcaemia after treatment with zoledronic acid in a patient with multiple myeloma. Ann Oncol 2004;15(12):1848 (Pubitemid 40012253)
23. Jones SG, Dolan G, Lengyel K, Myers B. Severe increase in creatinine with hypocalcaemia in thalidomide-treated myeloma patients receiving zoledronic acid infusions. Br J Haematol 2002;119(2):576-7 (Pubitemid 35365519)
24. Breen TL, Shane E. Prolonged hypocalcemia after treatment with zoledronic acid in a patient with prostate cancer and vitamin D deficiency. J Clin Oncol 2004;22(8):1531-2 (Pubitemid 41103642)
25. Tanvetyanon T, Stiff PJ. Management of the adverse effects associated with intravenous bisphosphonates. Ann Oncol 2006;17(6):897-907 (Pubitemid 43785797)
26. Hypponen E, Power C. Hypovitaminosis D in British adults at age 45 y: nationwide cohort study of dietary and lifestyle predictors. Am J Clin Nutr 2007;85(3):860-8 (Pubitemid 46393520)
27. Wang-Gillam A, Miles DA, Hutchins LF. Evaluation of vitamin D deficiency in breast cancer patients on bisphosphonates. Oncologist 2008;13(7):821-7
28. Pearce SH, Cheetham TD. Diagnosis and management of vitamin D deficiency. Br Med J 2010;340:b5664. http://www.pharma.us.novartis.com/product/pi/pdf/ Zometa.pdf
29. Kennel KA, Drake MT. Adverse effects of bisphosphonates: implications for osteoporosis management. Mayo Clin Proc 2009;J84(7):632-7, quiz 8
30. Chennuru S, Koduri J, Baumann MA. Risk factors for symptomatic hypocalcaemia complicating treatment with zoledronic acid. Int Med J 2008;38(8):635-7
31. 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(2):558-67 (Pubitemid 32112871)
32. Coleman RTH, Cameron D, Bell R, et al. Zoledronic acid is well tolerated and can be safely administered with adjuvant chemotherapy-first safety data from the AZURE trial (BIG01/04). San Antonio Breast Cancer Symposium. 2006. Breast Cancer Res Treat 2006;100(Suppl 1):abstract 2080
33. Berenson J, Hirschberg R. Safety and convenience of a 15-minute infusion of zoledronic acid. Oncologist 2004;9(3):319-29 (Pubitemid 38756880)
34. Markowitz GS, Fine PL, Stack JI, et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 2003;64(1):281-9
35. Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid. N Engl J Med 2003;349(17):1676-9
36. Rosen LS, Gordon D, Tchekmedyian NS, et al. 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(12):2613-21 (Pubitemid 38715767)
37. Perazella MA, Markowitz GS. Bisphosphonate nephrotoxicity. Kidney Int 2008;74(11):1385-93
38. Marx RE. Pamidronate (Aredia) And zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg 2003;61:1115-17
39. Migliorati CA. Bisphosphonates and oral cavity avascular bone necrosis. J Clin Oncol 2003;15:4253-4
40. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg 2004;62:527-34 (Pubitemid 38542516)
41. Marx RE, Cillo JE Jr, Ulloa JJ. Oral bisphosphonate-induced osteonecrosis: risk factors, prediction of risk using serum CTX testing, prevention, and treatment. J Oral Maxillofac Surg 2007;65:2397-410
42. Schwartz HC. Osteonecrosis of the jaws: a complication of cancer chemotherapy. Head Neck Surg 1982;4:251-3
43. Mirzai R, Chang C, Greenspan A, Gershwin ME. The pathogenesis of osteonecrosis and the relationships to corticosteroids. J Asthma 1999;36:77-95 (Pubitemid 29116995)
44. Donoghue AM. Bisphosphonates and osteonecrosis: analogy to phossy jaw. Med J Aust 2005;183:163-4 (Pubitemid 41087055)
45. Hellstein JW, Marek CL. Bisphosphonate osteochemonecrosis (bis-phossy jaw): is this phossy jaw of the 21st century? J Oral Maxillofac Surg 2005;63:682-9
46. Marx RE. Uncovering the cause of "phossy jaw" Circa 1858 to 1906: oral and maxillofacial surgery closed case files-case closed. J Oral Maxillofac Surg 2008;66:2356-63
47. Ruggiero SL, Fantasia J, Carlson E. Bisphosphonate-related osteonecrosis of the jaw: background and guidelines for diagnosis, staging and management. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2006a;102:433-41 (Pubitemid 44403162)
48. Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007;22:1479-91 (Pubitemid 351229318)
49. Migliorati CA, Casiglia J, Epstein J, et al. Managing the care of patients with bisphosphonate-associated osteonecrosis: an American Academy of Oral Medicine position paper. J Am Dent Assoc 2005;136:1658-68 (Pubitemid 41810027)
50. Ruggiero SL, Gralow J, Marx RE, et al. Practical guidelines for the prevention, diagnosis and treatment of osteonecrosis of the jaw in patients with cancer. J Clin Oncol Prac 2006b;2:7-14
51. Weitzman R, Sauter N, Eriksen EF, et al. Critical review: updated recommendations for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in cancer patients - May 2006. Crit Rev Oncol Hematol 2007;62:148-52
52. Altundag K, Bulut N, Tezcan E, et al. Tooth extraction: is it inciting event or sequela of osteonecrosis of the jaws associated with intravenous bisphosphonates? J Oral Maxillofac Surg 2007;65:154 (Pubitemid 44894693)
53. Hansen T, Kunkel M, Weber A, James Kirkpatrick C. Osteonecrosis of the jaws in patients treated with bisphosphonates - histomorphologic analysis in comparison with infected osteoradionecrosis. J Oral Pathol Med 2006;35:155-60
54. Ruggiero SL, Dodson TB, Assael LA, et al. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws-2009 update. J Oral Maxillofac Surg 2009;67:2-12
55. Colella G, Campisi G, Fusco V. (American Association of Oral and Maxillofacial Surgeons position paper: bisphosphonate-related osteonecrosis of the jaws-2009 update: the need to refine the BRONJ definition. J Oral Maxillofac Surg 2009;67:2698-9
56. Junquera L, Gallego L. Nonexposed bisphosphonate-related osteonecrosis of the jaws: another clinical variant? J Oral Maxillofac Surg 2008;66:1516-17 (Pubitemid 351822447)
57. Yarom N, Fedele S, Lazarovici TS, Elad S. Is exposure of the jawbone mandatory for establishing the diagnosis of bisphosphonate-related osteonecrosis of the jaw? J Oral Maxillofac Surg 2009;67(5 Suppl):2-12
58. Marx RE, Sawatari Y, Fortin M, Broumand V. Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: risk factors, recognition, prevention, and treatment. J Oral Maxillofac Surg 2005;63:1567-75
59. Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther 2002;302:1055-61 (Pubitemid 34920226)
60. Bouquot JE, Mcmahon RE. Neuropathic pain in maxillofacial osteonecrosis. J Oral Maxillofac Surg 2000;58:1003-20
61. Christodoulou C, Pervena A, Klouvas G, et al. Combination of bisphosphonates and antiangiogenic factors induces osteonecrosis of the jaw more frequently than bisphosphonates alone. Oncology 2009;76:209-11
62. Brunello A, Saia G, Bedogni A, et al. Worsening of osteonecrosis of the jaw during treatment with sunitinib in a patient with metastatic renal cell carcinoma. Bone 2009;44:173-5
63. Ayllon J, Launay-Vacher V, Medioni J, et al. Osteonecrosis of the jaw under bisphosphonate and antiangiogenic therapies: cumulative toxicity profile? Ann Oncol 2009;20:600-1
64. Greuter S, Schmid F, Ruhstaller T, Thurlimann B. Bevacizumab-associated osteonecrosis of the jaw. Ann Oncol 2009;19:2091-2
65. Estilo CL, Fornier M, Farooki A, et al. Osteonecrosis of the jaw related to bevacizumab. J Clin Oncol 2008;26:4037-8
66. Brown JE, Barrios CH, Diel IJ, et al. Incidence and outcomes of osteonecrosis of the jaw from an integrated analysis of three pivotal randomized double-blind, double-dummy phase 3 trials comparing denosumab and zoledronic acid for treatment of bone metastases in advanced cancer patients or myeloma. Cancer and Bone Society Proceedings 2010: abstract 15
67. Reid IR, Bolland MJ, Grey AB. Is bisphosphonate-associated osteonecrosis of the jaw caused by soft tissue toxicity? Bone 2007;41:318-20
68. Scheper MA, Badros A, Chaisuparat R, et al. Effect of zoledronic acid on oral fibroblasts and epithelial cells: a potential mechanism of bisphosphonate-associated osteonecrosis. Br J Haematol 2009;144:667-76
69. Wilkinson GS, Kuo YF, Freeman JL, Goodwin JS. Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: a population-based analysis. J Natl Cancer Inst 2007;99(13):1016-24
70. AAOMS. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg 2007;65:369-76
71. Almazrooa SA, Woo SB. Bisphosphonate and nonbisphosphonate-associated osteonecrosis of the jaw: a review. J Am Dent Assoc 2009;140:864-75
72. Hoff AO, Toth BB, Altundag K, et al. Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates. J Bone Miner Res 2008;23:826-36 (Pubitemid 351768801)
73. Dimopoulos MA, Kastritis E, Bamia C, et al. Reduction of osteonecrosis of the jaw (ONJ) after implementation of preventive measures in patients with multiple myeloma treated with zoledronic acid. Ann Oncol 2009;20:117-20
74. Ripamonti CI, Manniezzo M, Campa T, et al. Decreased occurrence of osteonecrosis of the jaw after implementation of dental preventive measures in solid tumour patients with bone metastases treated with bisphosphonates. The experience of the National Cancer Institute of Milan. Ann Oncol 2009;20(1):137-45
75. Corso A, Varettoni M, Zappasodi P, et al. A different schedule of zoledronic acid can reduce the risk of the osteonecrosis of the jaw in patients with multiple myeloma. Leukemia 2007;21:1545-8 (Pubitemid 46965296)
76. Schwartz HC. Bisphosphonate-associated osteonecrosis of the jaws. J Oral Maxillofac Surg 2005;63:1555-6
77. Landis BN, Richter M, et al. Osteonecrosis of the jaw after treatment with bisphosphonates: is irreversible, so the focus must be on prevention. Br Med J 2006;333:982-3
78. Stanton DC, Balasanian E. Outcome of surgical management of bisphosphonate-related osteonecrosis of the jaws: review of 33 surgical cases. J Oral Maxillofac Surg 2009;67:943-50
79. Pazanias M, Compston J, Huang CL-H. Atrial fibrillation and bisphosphonate therapy. J Bone Miner Res 2010;25:2-10
80. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation. N Engl J Med 2007;356:1895-96
81. Camm AJ. Review of the cardiovascular safety of zoledronic acid and other bisphosphonates for the treatment of osteoporosis. Clin Ther 2010;32:426-36
82. Lyles KW, Colon-Emeric CS, Magaziner JS, et al.; for the HORIZON Recurrent Fracture Trial. Zoledronic acid in reducing clinical fracture and mortality after hip fracture. N Engl J Med 2007;357:1799-809
83. Lipton A. The safety of zoledronic acid. Expert Opin Drug Saf 2007;6:305-13 (Pubitemid 46772849)
84. Tanvetyanon T, Stiff PJ. Management of the adverse effects associated with intravenous bisphosphonates. Ann Oncol 2006;17:897-907 (Pubitemid 43785797)
85. Colucci A, Modorati G, Miserocchi E, et al. Anterior uveitis complicating zoledronic acid infusion. Ocul Immunol Inflamm 2009;17:267-8
86. Kilickap S, Ozdamar Y, Altundag MK, Dizdar O. A case report: zoledronic acid-induced anterior uveitis. Med Oncol 2008;25:238-40
87. Banal F, Briot K, Ayoub G, et al. Unilateral anterior uveitis complicating zoledronic acid therapy in prostate cancer. J Rheumatol 2008;35:2458-9
88. Moore MM, Beith JM. Acute unilateral anterior uveitis and scleritis following a single infusion of zoledronate for metastatic breast cancer. Med J Aust 2008;188:370-1
89. Durnian JM, Olujohungbe A, Kyle G. Bilateral acute uveitis and conjunctivitis after zoledronic acid therapy. Eye (Lond) 2005;19:221-2 (Pubitemid 40309512)
90. Huang J, Meixner L, Fernandez S, McCutchan JA. A double-blinded, randomized controlled trial of zoledronate therapy for HIV-associated osteopenia and osteoporosis. AIDS. 2009;23:51-7
91. Woo TC, Joseph DJ, Wilkinson R. Serious ocular complications of zoledronate. Clin Oncol (R Coll Radiol) 2006;18:545-46 (Pubitemid 44123545)
92. Lee P, van der Wall H, Siebel MJ. Looking beyond low bone mineral density: multiple insufficiency fractures in a woman with post-menopausal osteoporosis on alendronate therapy. J Endocrinol Invest 2007;30:590-7 (Pubitemid 47577812)
93. Lenart BA, Lorich DG, Lane JM. Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med 2008;358:304-06
94. Kwek EB, Goh SK, Koh JS, et al. An emerging pattern of sub-trochanteric stress fractures: a long term complication of alendronate therapy? Injury 2008;39:224-31
95. Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. New Engl J Med 2010;362:1761-71
96. Visekruna M, Wilson D, McKiernan E. Severely suppressed bone turnover and atypical bone fragility. J Clin Endocrinol Metab 2008;93:2948-52
97. Whyte MP. Atypical femoral fractures, bisphosphonates and adult hypophosphatasia. J Bone Miner Res 2009;24:1132-34
98. Nieves JW, Cosman F. Atypical subtrochanteric and femoral fractures and possible association with bisphosphonates. Curr Osteoporos Rep 2010;8:34-9
99. Giusti A, Hamdy NAT, Papapoulos SE. Atypical fractures of the femur and bisphosphonate therapy. A systematic review of case/case series studies. Bone 2010;47(2):169-80
100. Girgis CM, Sher D, Siebel MJ. Atypical femoral fractures and bisphosphonate use. N Engl J Med 2010;362:1848-49
101. Abrahamsen B. Adverse effects of bisphosphonates. Calcif Tissue Int 2010;86:421-35
102. Seeman. To stop or not to stop, that is the question. Osteoporos Int 2009;20:187-95
103. Black DM, Kelly MO, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. New Engl J Med 2010;362:1761-71
104. Biswas PN, Wilton L, Harris S, et al. Pharmacovigilance study of alendronate in England. Osteoporos Int 2003;14:507-14 (Pubitemid 36919212)
105. Body JJ, Coleman R, Clezardin P, et al. International Society of Geriatric Oncology (SIOG) clinical practice recommendations for the use of bisphosphonates in elderly patients. Eur J Cancer 2007;43(5):852-8 (Pubitemid 46366687)
106. Saad F, Gleason DM, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002;94:1458-68
107. Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 2009;360:679-91