The safety of zoledronic acid

Expert Opinion on Drug Safety

Volumn 6, Issue 3, 2007, Pages 305-313

  Lipton, Allan ^a  

^a PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

Author keywords

Bisphosphonate; Bone metastasis; Osteonecrosis of the jaw; Renal function

Indexed keywords

ANTIBIOTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; CREATININE; NONSTEROID ANTIINFLAMMATORY AGENT; PAMIDRONIC ACID; PARACETAMOL; PLACEBO; VITAMIN D; ZOLEDRONIC ACID; ANTINEOPLASTIC AGENT; IMIDAZOLE DERIVATIVE;

ANEMIA; ANOREXIA; ARTHRALGIA; BLOOD CHEMISTRY; BONE DISEASE; BONE METASTASIS; BONE NECROSIS; BONE PAIN; BREAST CANCER; CLINICAL TRIAL; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; COUGHING; CRANIAL NERVE PARALYSIS; CREATININE BLOOD LEVEL; DENTAL CARE; DIARRHEA; DOSE CALCULATION; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG REEXPOSURE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ELECTROLYTE DISTURBANCE; EPISCLERITIS; EYE INFLAMMATION; EYELID EDEMA; FATIGUE; FLU LIKE SYNDROME; HEMATOLOGY; HUMAN; HYPERCALCEMIA; HYPOCALCEMIA; HYPOMAGNESEMIA; INJECTION SITE REACTION; JAW DISEASE; KIDNEY DYSFUNCTION; LABORATORY TEST; MOUTH HYGIENE; MULTIPLE MYELOMA; MYALGIA; NAUSEA; OSTEOPOROSIS; PERIPHERAL EDEMA; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCLERITIS; SIDE EFFECT; TREATMENT DURATION; UVEITIS; VOMITING; WEAKNESS; BLOOD; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; KIDNEY; PHYSIOLOGY;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; CREATININE; DIPHOSPHONATES; HUMANS; IMIDAZOLES; JAW DISEASES; KIDNEY; OSTEONECROSIS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 34248571550     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.6.3.305     Document Type: Review

References (53)

1. COLEMAN RE: Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat. Rev. (2001) 27(3):165-176.
2. WEINFURT KP, CASTEL LD, LI Y, TIMBIE JW, GLENDENNING GA, SCHULMAN KA: Health-related quality of life among patients with breast cancer receiving zoledronic acid or painidronate disodium for metastatic bone lesions. Med. Care (2004) 42(2):164-175.
3. WEINFURT KP, LI Y, CASTEL LD et al.: The significance of skeleral-related events for the health-related quality of life of patients with metastatic prostate cancer. Ann. Oncol. (2005) 16(4):579-584.
4. HEI Y. SAAD F, COLEMAN RE, CHEN Y-M: Fractures negatively affect survival in patients with bone metastases from breast cancer. SABCS - the 28th Annual San Antonio Breast Cancer Symposium. San Antonio, Texas, USA (2005). Abstract 6036.
5. SAAD F, COLEMAN R, COOK R, BROWN JE, HEI Y, CHEN Y-M: Pathologic fractures and bone markers are predictors of clinical outcome in patients with prostate cancer and bone metastases. 2006 Prostate Cancer Symposium: A Multidisciplinary Approach Program/Proceedings. San Francisco, California, USA (2006):168 Abstract 150.
6. ROSEN LS, GORDON D, KAMINSKI M et al.: Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer (2003) 98(8):1735-1744.
7. ROSEN LS, GORDON D, TCHEKMEDYLkN 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):2613-2621.
8. SAAD F, GLEASON DM, MURRAY R et al.: Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J. Natl. Cancer Inst. (2004) 96(11):879-882.
9. WONG R, WIFFEN PJ: Bisphosphonates for the relief of pain secondary to bone merastases (Cochrane Review). In: The Cochrane Library (Issue 1). John Wiley & Sons Ltd, Chichester, UK (2004).
10. LIPTON A, THERIAULT RL, HORTOBAGYI GN et al.: Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer (2000) 88(5):1082-1090.
11. BODY J-J, DIEL IJ, LICHINITSER MR et al.: Intravenous ibandronare reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann. Oncol. (2003) 14(9):1399-1405.
12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Prostate Cancer. (Version 2.2005). Jenkintown, Pennsylvania, USA.
13. AUS G, ABBOU CC, BOLLA M et al.: EAU guidelines on prostate cancer. Eur. Urol. (2005) 48(4):546-551.
14. HILLNER BE, INGLE JN, CHLEBOWSKI RT et al.: American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J. Clin. Oncol. (2003) 21(21):4042-4057.
15. KOHNO N, AOGI K, MINAMI H et al.: Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastates from breast cancer: a randomized, placebo-comrolled trial. J. Clin. Oncol. (2005) 23(15):3314-3321.
16. CONTE P, GUARNERI V. Safety of intravenous and oral bisphosphonates; and compliance with dosing regimens. Oncologist (2004) 9(Suppl. 4):28-37.
17. TANVETYANON T, STIFF PJ: Management of the adverse effects associated with intravenous bisphosphonates. Ann. Oncol. (2006) 17(6):897-907.
18. 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(19):1458-1468.
19. CHEN T, BERENSON J, VESCIO R et al.: Pharmacokinetics and pharmacodynamics of zoledronic acid in cancer patients with bone metastases. Clin. Pharmacol. (2002) 42(11):1228-1236.
20. ZOMETA®: Zoledronic acid injection concentrate for intravenous infusion [prescribing information]. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA (2005).
21. LIPTON A, DEWAR R, CONTE P, ZHENG M: Long-term safety of zoledronic acid for the treatment of patients with breast cancer and bone metastases. 4th European Breast Cancer Conference. Hamburg, Germany (2004). Poster 296.
22. SAAD F, GLEASON D, MURRAY R et al.: Zoledronic acid is well tolerated for up to 24 months and significantly reduces skeletal complications in patients with advanced prostate cancer metastatic to bone. American Urological Association Annual Meeting. Chicago, Illinois, USA (2003). Abstract 1472.
23. AUGUSTSON BM, BEGUM G, DUNN JA et al.: Early mortality after diagnosis of multiple myeloma: analysis of patients entered onto the United Kingdom. Medical Research Council trials between 1980 and 2002 - Medical Research Council Adult Leukaemia Working Party. J. Clin. Oncol. (2005) 23(36):9219-9226.
24. GAVRILOV V, YERMIAHU T, GORODISCHER R: Renal pathology and retinol status in multiple myeloma patients. Kidney Int. (2006) 69(1):173-177.
25. BERENSON JR, LICHTENSTEIN A, PORTER L et al.: Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. J. Clin. Oncol. (1998) 16(2):593-602.
26. ALI SM, ESTEVA FJ, HORTOBAGYI G et al.: Safety and efficacy of bisphosphonates beyond 24 months in cancer patients. J. Clin. Oncol. (2001) 19(14):3434-3437.
27. GUARNERI V, DONATI S, NICOLINI M, GIOVANNELLI S, D'AMICO R, CONTE PF: Renal safety and efficacy of i.v. bisphosphonates in patients with skeletal merastases treated for up to 10 years. Oncologist (2005) 10(10):842-848.
28. VOGEL CL: Zoledronic acid: open-label, US trial evaluating pain, infusion time, quality of life and safety including a subset of patients on prior bisphosphonate therapy (US 16) [abstract 3031]. Proc. Am. Soc. Clin. Oncol. (2003) 22:754.
29. YANAGIHARA R, VOGEL CL, WOOD AJ et al.: Safety of zoledronic acid in patients who have previously received bisphosphonate therapy [abstract 8156]. J. Clin. Oncol. (2004) 23:764.
30. BERENSON JR, HILLNER BE, KYLE RA et al.: American Society of Clinical Oncology clinical practice guidelines: the role of bisphosphonates in multiple myeloma. J. Clin. Oncol. (2002) 20(17):3719-3736.
31. DURNIAN JM, OLUJOHUNGBE A, KYLE G: Bilateral acute uveitis and conjunctivitis after zoledronic acid therapy. Eye (2005) 19(2):221-222.
32. EL SAGHIR NS, OTROCK ZK, BLEIKJH: Unilateral anterior uveitis complicating zoledronic acid therapy in breast cancer. BMC Cancer (2005) 5:156.
33. FRAUNFELDER FW, FRAUNFELDER FT: Bisphosphonates and ocular inflammation. N. Engl. J. Med. (2003) 348(12):1187-1188.
34. MIGLIORATI CA, SIEGEL MA, ELTING LS: Bisphosphonate-associated osteonecrosis: a long-term complication of bisphosphonate treatment. Lancet Oncol. (2006) 7(6):508-514.
35. HOFF AO, TOTH BB, ALTUNDAG K et al.: Osteonecrosis of the jaw in patients receiving intravenous bisphosphonate therapy. 42nd Annual Meeting of the American Society of Clinical Oncology. Atlanta, Georgia, USA (2006). Abstract 8528.
36. VAN DEN WYNGAERT T, HUIZING MT, VERMORKEN JB: Bisphosphonates and osteonecrosis of the jaw: cause and effect or a post hoc fallacy? Ann. Oncol. (2006) 17(8):1197-1204.
37. MEHROTRA B, RUGGIERO S: Bisphosphonate complications including osteonecrosis of the jaw. Hematology Am. Soc. Hematol. Educ. Program (2006):356-360.
38. DIMOPOULOS MA. KASTRITIS E, ANAGNOSTOPOULOS A et al.: Osteonecrosis of the jaw in patients with multiple myeloma treated with bisphosphonates: evidence of increased risk after treatment with zoledronic acid. Haematologica (2006) 91(7):968-971.
39. CHANG JT, GREEN L, BEITZ J: Renal failure with the use of zoledronic acid. N. Engl. J. Med. (2003) 349(17):1676-1679.
40. RUGGIERO S, GRALOW J, MARX RE et al.: Practical guidelines for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in patients with cancer. J. Oncol. Practice (2006) 2(1):7-14.
41. MIGLIORATI CA, CASIGLIA J, EPSTEIN J, JACOBSEN PL, SIEGEL MA, WOO SB: Managing the care of patients with bisphosphonate-associated osteonecrosis: an American Academy of Oral Medicine position paper. J. Am. Dent. Assoc. (2005) 136(12):1658-1668.
42. 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(2):148-152.
43. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Multiple Myeloma. (Version 1.2007). Jenkintown, Pennsylvania, USA.
44. LACY MQ, DISPENZIERI A, GERTZ MA et al.: Mayo clinic consensus statement for the use of bisphosphonates in multiple myeloma. Mayo Clin. Proc. (2006) 81(8):1047-1053.
45. COSTA L, CHEN Y-M, SHIRINA N: Breast cancer patients without pain are at risk for skeletal-related events (SREs) and may have better outcomes with zoledronic acid compared with pamidronate. 31st European Society for Medical Oncology. Istanbul, Turkey (2006).
46. MAJOR P, HIRSH V, LIPTON A, COOK R, LANGER C, SHIRINA N: Zoledronic acid may improve survival in lung cancer patients with high baseline bone market levels [abstract 739PD]. 31st European Society for Medical Oncology. Istanbul, Turkey (2006).
47. BERENSON J, SHIRINA N, CHEN Y-M: Zoledronic acid is associated with a survival benefit in patients with multiple myeloma stratified by baseline bone alkaline phosphatase levels [abstract 1621]. Multinational Association of Supportive Care in Cancer (MASCC)/ International Society for Oral Oncology (ISOO) 18th International Symposium. Toronto, ON, Canada (2006).
48. LIPTON A, HEI Y-J, COLEMAN RE, MAJOR P, SMITH MR, COOK RJ: Normalization of urinary N-telopeptide levels by zoledronic acid correlates with improved survival in patients with bone metastases from breast cancer [abstract 3015]. 29th Annual San Antonio Breast Cancer Symposium. San Antonio, Texas, USA (2006).
49. KOPEC IC, GROEGER JS: Life-threatening fluid and electrolyte abnormalities associated with cancer. Crit. Care. Clin. (1988) 4(1):81-105.
50. BERTELLI G, HEOUAINE A, ARENA G et al.: Weekly docetaxel and zoledronic acid every 4 weeks in hormone-refractory prostate cancer patients. Cancer Chemother. Pharmacol. (2006) 57(1):46-51.
51. VORDOS D, PAULE B, VACHEROT F et al.: Docetaxel and zoledronic acid in patients with metastatic hormone-refractory prostate cancer. BJU Int. (2004) 94(4):524-527.
52. EFSTATHIOU E, BOZAS G, KOSTAKOPOULOS A et al.: Combination of docetaxel, estramustine phosphate, and zoledronic acid in androgen-independent metastatic prostate cancer: efficacy, safety, and clinical benefit assessment. Urology (2005) 65(1):126-130.
53. TOSI P, ZAMAGNI E, CELLINI C et al.: First-line therapy with thalidomide, dexamethasone and zoledronic acid decreases bone resorption markers in patients with multiple myeloma. Eur. J. Haematol. (2006) 76(5):399-404.