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Recommendations for use of Bisphosphonates

References

1. National Breast Cancer Centre. Clinical practice guidelines for the management of early breast cancer: Second edition. Canberra: Commonwealth of Australia 2001.

2. National Breast and Ovarian Cancer Centre. Recommendations for use of bisphosphonates for advanced breast cancer. Surry Hills: NBOCC 2011.

3. National Breast Cancer Centre and National Cancer Control Initiative. Clinical practice guidelines for the psychosocial care of adults with cancer. Camperdown: National Breast Cancer Centre 2003.

4. National Health and Medical Research Council. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Canberra: Commonwealth of Australia 2009.

5. McCloskey E, Paterson A, Kanis J, Tahtela R, Powles T. Effect of oral clodronate on bone mass, bone turnover and subsequent metastases in women with primary breast cancer. Eur J Cancer. 2010;46(3):558-65.

6. Saarto T, Vehmanen L, Blomqvist C, Elomaa I. Ten-year follow-up of 3 years of oral adjuvant clodronate therapy shows significant prevention of osteoporosis in early-stage breast cancer. J Clin Oncol. 2008;26(26):4289-95.

7. Lester JE, Dodwell D, Purohit OP, et al. Prevention of anastrozole-induced bone loss with monthly oral ibandronate during adjuvant aromatase inhibitor therapy for breast cancer. Clin Cancer Res. 2008;14(19):6336-42.

8. Kristensen B, Ejlertsen B, Mouridsen HT, et al. Bisphosphonate treatment in primary breast cancer: results from a randomised comparison of oral pamidronate versus no pamidronate in patients with primary breast cancer. Acta Oncol. 2008;47(4):740-6.

9. Greenspan SL, Brufsky A, Lembersky BC, et al. Risedronate prevents bone loss in breast cancer survivors: a 2-year, randomized, double-blind, placebo-controlled clinical trial. J Clin Oncol. 2008;26(16):2644-52.

10. Van Poznak C, Hannon RA, Mackey JR, et al. Prevention of aromatase inhibitor-induced bone loss using risedronate: the SABRE trial. J Clin Oncol. 2010;28(6):967-75.

11. Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med. 2009;360(7):679-91.

12. Hershman DL, McMahon DJ, Crew KD, et al. Prevention of bone loss by zoledronic acid in premenopausal women undergoing adjuvant chemotherapy persist up to one year following discontinuing treatment. J Clin Endocrinol Metab. 2010;95(2):559-66.

13. Brufsky A, Bundred N, Coleman R, et al. Integrated analysis of zoledronic acid for prevention of aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole. Oncologist. 2008;13(5):503-14.

14. Edwards BJ, Hellstein JW, Jacobsen PL, et al. Updated recommendations for managing the care of patients receiving oral bisphosphonate therapy: an advisory statement from the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008;139(12):1674-7.

15. 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 Pract. 2006;2(1):7-14.

16. 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(10):1479-91.

17. Brufsky A, Harker WG, Beck JT, et al. Zoledronic acid inhibits adjuvant letrozole-induced bone loss in postmenopausal women with early breast cancer. J Clin Oncol. 2007;25(7):829-36.

18. Bundred NJ, Campbell ID, Davidson N, et al. Effective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: ZO-FAST Study results. Cancer. 2008;112(5):1001-10.

19. Valachis A, Polyzos NP, Georgoulias V, Mavroudis D, Mauri D. Lack of evidence for fracture prevention in early breast cancer bisphosphonate trials: a meta-analysis. Gynecol Oncol. 2010;117(1):139-45.

20. Pavlakis N, Schmidt R, Stockler M. Bisphosphonates for breast cancer. Cochrane database of systematic reviews (Online). 2005(3):CD003474.

21. Diel IJ, Jaschke A, Solomayer EF, et al. Adjuvant oral clodronate improves the overall survival of primary breast cancer patients with micrometastases to the bone marrow: a long-term follow-up. Ann Oncol. 2008;19(12):2007-11.

22. Gnant M, Mlineritsch B, Stoeger H, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol. 2011;12(7):631-41

23. Gnant M, Mlineritsch B, Luschin-Ebengreuth G, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy. Lancet Oncol. 2008;9(9):840-9.

24. Hines SL, Mincey B, Dentchev T, et al. Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC. Breast Cancer Res Treat. 2009;117(3):603-9.

25. Hines SL, Mincey BA, Sloan JA, et al. Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer. J Clin Oncol. 2009;27(7):1047-53.

26. Greenspan SL, Bhattacharya RK, Sereika SM, Brufsky A, Vogel VG. Prevention of bone loss in survivors of breast cancer: A randomized, double-blind, placebo-controlled clinical trial. J Clin Endocrinol Metab. 2007;92(1):131-6.

27. van Londen GJ, Perera S, Vujevich KT, et al. Effect of risedronate on hip structural geometry: a 1-year, double-blind trial in chemotherapy-induced postmenopausal women. Bone. 2008;43(2):274-8.

28. van Londen GJ, Perera S, Vujevich KT, et al. The effect of risedronate on hip structural geometry in chemotherapy-induced postmenopausal women with or without use of aromatase inhibitors: a 2-year trial. Bone. 2010;46(3):655-9.

29. Eidtmann H, de Boer R, Bundred N, et al. Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST Study. Ann Oncol. 2010;21(11):2188-94.

30. Brufsky AM, Bosserman LD, Caradonna RR, et al. Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clin Breast Cancer. 2009;9(2):77-85.

31. Mauri D, Valachis A, Polyzos IP, et al. Osteonecrosis of the jaw and use of bisphosphonates in adjuvant breast cancer treatment: a meta-analysis. Breast Cancer Res Treat. 2009;116(3):433-9.

32. Cancer Australia. Bisphosphonates in early breast cancer: a systematic literature review. Surry Hills: Cancer Australia 2011.

33. Ha TC & Li H. Meta-analysis of clodronate and breast cancer survival. Br J Cancer. 2007;96(12):1796-801.

34. Mauri D, Valachis A, Polyzos NP, et al. Does adjuvant bisphosphonate in early breast cancer modify the natural course of the disease? A meta-analysis of randomized controlled trials. J Natl Compr Canc Netw. 2010;8(3):279-86.

35. Diel IJ, Solomayer EF, Costa SD, et al. Reduction in new metastases in breast cancer with adjuvant clodronate treatment. N Engl J Med. 1998;339(6):357-63.

36. The Royal Australian College of General Practitioners (RACGP). Clinical guideline for the prevention and treatment of osteoporosis in postmenopausal women and older men. South Melbourne: RACGP 2010.

37. Mann GB, Kang YC, Brand C, Ebeling PR, Miller JA. Secondary causes of low bone mass in patients with breast cancer: a need for greater vigilance. J Clin Oncol. 2009;27(22):3605-10.

38. Voelker R. "Disappointing" Trial Results Offer Hope for Older Women With Breast Cancer. JAMA. 2011;305(8):765-6.

39. Coleman RE, Thorpe HC, Cameron D, et al. Adjuvant treatment with zoledronic acid in stage II/III breast cancer. The AZURE trial (BIG 01/04). San Antonio Breast Cancer Symposium 2010; 8-12 December, 2010; San Antonio 2010. p. S4-5.

40. Pharmaceutical Benefits Scheme. Canberra: Commonwealth of Australia; Accessed April 2011; Available at: www.pbs.gov.au.

41. Shapiro CL, Halabi S, Hars V, et al. Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809. Eur J Cancer. 2011;47(5):683-9.

42. Diel IJ, Bergner R, Grotz KA. Adverse effects of bisphosphonates: current issues. J Support Oncol. 2007;5(10):475-82.

43. National Breast and Ovarian Cancer Centre. Bisphosphonates for advanced breast cancer: a systematic review. Surry Hills: NBOCC 2010.

44. Coleman R, Woodward E, Brown J, et al. Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for women with stage II/III breast cancer. Breast Cancer Res Treat. 2011;127(2):429-38

45. Ripamonti CI, Maniezzo 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.

46. Schilcher J, Michaelsson K, Aspenberg P. Bisphosphonate use and atypical fractures of the femoral shaft. N Engl J Med. 2011;364(18):1728-37.

47. ClinicalTrials.gov. Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE). Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT01077154.

48. ClinicalTrials.gov. Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy [ABCSG-18]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00556374.

49. ClinicalTrials.gov. AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer [NCT00089661]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00089661.

50. Stopeck AT, Lipton A, Body JJ, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28(35):5132-9.

51. ClinicalTrials.gov. HOBOE: A Study of Hormonal Adjuvant Treatment Effect on Bone Mineral Density in Early Breast Cancer Patients. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00412022.

52. ClinicalTrials.gov. A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss [CZOL446GDE13]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00333229.

53. ClinicalTrials.gov. Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer [NSABP B-34]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00009945.

54. ClinicalTrials.gov. A Study to Compare ETC vs. EC-TX and Ibandronate vs. Observation in Patients With Node-Positive Primary Breast Cancer [GAIN]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00196872.

55. Current Controlled Trials. TEAM II: a randomised, multicentre, prospective, phase III trial investigating neoadjuvant hormonal therapy with exemestane for three versus six months (TEAM IIa) and/or the efficacy and safety of the addition of ibandronate to adjuvant hormonal therapy in post-menopausal women with hormone receptor positive early breast cancer (TEAM IIb) Accessed: June 2011; Available at: http://www.controlled-trials.com/ISRCTN17633610/ISRCTN17633610.

56. ClinicalTrials.gov. Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer [AZURE]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00072020.

57. ClinicalTrials.gov. Effectiveness of Zoledronic Acid in the Prevention of Osteoporosis in Early Breast Cancer Patients Receiving Letrozole [NCT00376740]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00376740.

58. ClinicalTrials.gov. Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer [CFEM345D2405]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00171340.

59. ClinicalTrials.gov. Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer [CALGB-79809]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00022087.

60. WHO International Clinical Trials Registry Platform. Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy [JPRN-UMIN000001104]. Accessed: June 2011; Available at: http://apps.who.int/trialsearch/trial.aspx?trialid=JPRN-UMIN000001104.

61. ClinicalTrials.gov. Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer [CFEM345DDE09]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00332709.

62. ClinicalTrials.gov. Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer [SWOG-S0307]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00127205.

63. ClinicalTrials.gov. Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy (REBBeCA II). Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00485953.

64. ClinicalTrials.gov. Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer (RISAROS). Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00859703.

65. ClinicalTrials.gov. Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer [CZOL446GDE19]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00375752.

66. ClinicalTrials.gov. Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy [CZOL446GCA08]. Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00247650.

67. ClinicalTrials.gov. Investigating the Biological Effects of the Addition of Zoledronic Acid to Pre-operative Chemotherapy in Breast Cancer (ANZAC). Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00525759.

68. ClinicalTrials.gov. Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy (NATAN). Accessed: June 2011; Available at: http://www.clinicaltrials.gov/ct2/show/NCT00512993.

Note Recent results and information from Coleman (2010 (#39), 2011 (#44)), Eidtmann (2010)(#29), Gnant (2011)(#22), Schilcher (2011)(#46) and Shapiro (2011)(#41) are included in this guideline, although these results were published after the Cancer Australia systematic review was conducted.

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