Journal of Oral and Maxillofacial Surgery
Volume 65, Issue 3 , Pages 369-376 , March 2007

American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws

  • Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws

      Affiliations

    • Corresponding Author InformationAddress correspondence and reprint requests to: AAOMS, 9700 W Bryn Mawr Ave, Rosemont, IL 60018.

References 

  1. Nussbaum SR, Younger J, Vandepol CJ, et al. Single-dose intravenous therapy with pamidronate for the treatment of hypercalcemia of malignancy: Comparison of 30-, 60-, and 90-mg dosages. Am J Med. 1993;95:297
  2. 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;19:558
  3. Hortobagyi GN, Theriault RL, Porter L, et al. Protocol 19 Aredia Breast Cancer Study Group Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. N Engl J Med. 1996;335:1785
  4. Hortobagyi GN, Theriault RL, Lipton A, et al. Protocol 19 Aredia Breast Cancer Study Group Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. J Clin Oncol. 1998;16:2038
  5. Hillner BE, Ingle JN, Chelbowski 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;21:4042
  6. 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
  7. 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;96:879
  8. 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 non-small cell lung carcinoma and other solid tumors: A randomized, Phase III, double-blind placebo-controlled trial. Cancer. 2004;100:2613
  9. Berenson JR, Lichtenstein A, Porter L, et al. Myeloma Aredia Study Group Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. N Engl J Med. 1996;334:488
  10. Berenson JR, Lichtenstein A, Porter L, et al. Myeloma Aredia Study Group Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. J Clin Oncol. 1998;16:593
  11. Rosen LS, Gordon D, Kaminski M, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III double-blind, comparative trial. Cancer J. 2002;7:377
  12. 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;20:3719
  13. Physicians’ Desk Reference. (ed 57). Montvale, NJ: Medical Economics; 2003;
  14. Delmas PD, Meunier PJ. The management of Paget’s disease of bone. N Engl J Med. 1997;336:558
  15. Letocha AD, Cintas HL, Troendle JF, et al. Controlled trial of pamidronate in children with types III and IV osteogenesis imperfecta confirms vertebral gains but not short-term functional improvement. J Bone Miner Res. 2005;20:977
  16. Watts NB. Bisphosphonate treatment of osteoporosis. Clin Geriatr Med. 2003;19:395
  17. Delmas PD. The use of bisphosphonates in the treatment of osteoporosis. Curr Opin Rheumatol. 2005;17:462
  18. Haderslev KV, Tjellesen L, Sorensen HA, et al. Alendronate increases lumbar spine bone mineral density in patients with Crohn’s disease. Gastroenterology. 2000;119:639
  19. Zein CO, Jorgensen RA, Clarke B, et al. Alendronate improves bone mineral density in primary biliary cirrhosis: A randomized placebo-controlled trial. Hepatology. 2005;42:762
  20. Bone HG, Hosking D, Devogelaer JP, et al. Ten years’ experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med. 2004;350:1189
  21. Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: A growing epidemic. J Oral Maxillofac Surg. 2003;61:1115
  22. Ruggiero SL, Mehrotra B, Rosenberg TJ, et al. Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. J Oral Maxillofac Surg. 2004;62:527
  23. Estilo CL, Van Posnak CH, Williams T, et al. Osteonecrosis of the maxilla and mandible in patients treated with bisphosphonates: A retrospective study. J Clin Oncol Proc Am Soc Clin Oncol. 2004;22:8088
  24. Marx RE, Sawatari Y, Fortin M, et al. Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: Risk factors, recognition, prevention and treatment. J Oral Maxillofac Surg. 2005;63:1567
  25. Migliorati CA, Schubert MM, Peterson DE, et al. Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone: An emerging oral complication of supportive cancer therapy. Cancer. 2005;104:83
  26. Purcell PM, Boyd IW. Bisphosphonates and osteonecrosis of the jaw. Med J Aust. 2005;182:417
  27. Bagan JV, Jimenez Y, Murillo J, et al. Jaw osteonecrosis associated with bisphosphonates: Multiple exposed areas and its relationship to teeth extractions (Study of 20 cases). Oral Oncol. 2006;42:327
  28. Pires FR, Miranda A, Cardoso ES, et al. Oral avascular bone necrosis associated with chemotherapy and bisphosphonate therapy. Oral Dis. 2005;11:365
  29. Woo SB, Hellstein JW, Kalmar JR. Systematic review: Bisphosphonates and osteonecrosis of the jaws. Ann Intern Med. 2006;144:753
  30. Woo SB, Hande K, Richardson PG. Osteonecrosis of the jaws and bisphosphonates. N Engl J Med. 2005;353:100
  31. Hohnecker JA: Novartis “Dear Doctor” precautions added to label of Aredia and Zometa. September 24, 2004
  32. US Food and Drug Administration Oncologic Drugs Advisory Committee: Combidex briefing information. http://www.fda.gov/ohms/dockets/ac/05/briefing/2005-4095B2_02_08-Novartis-Zometa-App-7.pdf. Accessed August 14, 2006
  33. U.S. Food and Drug Administration Office of Drug Safety: Postmarketing Safety Review. Available at: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4095B2_03_04-FDA-TAB3.pdf - 03-02-2005. Accessed August 14, 2006
  34. Durie BGM, Katz M, Crowley J. Osteonecrosis of the jaws and bisphosphonates. N Engl J Med. 2005;353:99
  35. Bamias A, Kastritis E, Bamia C, et al. Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: Incidence and risk factors. J Clin Oncol. 2005;23:8580
  36. 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;[Epub ahead of print]
  37. Dimopoulos M, Kastritis E, Moulopoulos LA, et al. The incidence of osteonecrosis of the jaw in patients with multiple myeloma who receive bisphosphonates depends on the type of bisphosphonate. Blood (American Society of Hematology Annual Meeting Abstracts). 2005;106:637
  38. Tosi P, Zamagni E, Cangini D, et al. Bisphosphonates and osteonecrosis of the jaws: Incidence in a homogeneous series of patients with newly diagnosed multiple myeloma treated with zoledronic acid. Blood (American Society of Hematology Annual Meeting Abstracts). 2005;106:3461
  39. Pozzi S, Marcheselli R, Sacchi S, et al. Analysis of frequency and risk factors for developing bisphosphonate associated necrosis of the jaw. Blood (American Society of Hematology Annual Meeting Abstracts). 2005;106:5057
  40. Cafro AM, Barbarano LA, Andriani A, et al. Osteonecrosis of the jaw associated with chroninc bisphosphonates therapy: An Italian experience. Blood (American Society of Hematology Annual Meeting Abstracts). 2005;106:5152
  41. Zavras AI, Zhu S. Bisphosphonates are associated with increased risk for jaw surgery in medical claims data: Is it osteonecrosis?. J Oral Maxillofac Surg. 2006;64:917
  42. Hoff AO, Toth BB, Altundag K, et al: Osteonecrosis of the jaw in patients receiving intravenous bisphosphonate therapy. J Clin Oncol 2006 ASCO Annual Meeting Proceedings (post meeting edition). 24:8528, 2006. Available at: http://meeting.jco.org/cgi/content/abstract/24/18_suppl/8528. Accessed August 14, 2006
  43. IMS HEALTH, NPA Plus May 2006
  44. Report of the Council of Scientific Affairs. Expert panel recommendations: Dental management of patients on oral bisphosphonate therapy. American Dental Association. June 2006. Available at: http://www.ada.org/prof/resources/topics/osteonecrosis.asp. Accessed June 29, 2006
  45. Badros A, Weikel D, Salama A, et al. Osteonecrosis of the jaw in multiple myeloma patients: Clinical features and risk factors. J Clin Oncol. 2006;24:945
  46. 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 Path Oral Radiol Endod. 2006;102:433
  47. 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. 2006;2:7
  48. Migliorati CA, Casiglia J, Epstein J, et al. Managing the care of patients with bisphosphonate-associated osteonecrosis. J Am Dent Assoc. 2005;136:1658
  49. American Association of Endodontists: Position Statement: Endodontic implications of bisphosphonate-associated osteonecrosis of the jaws. Available at: http://www.aae.org/dentalpro/guidelines.htm. Accessed August 14, 2006
  50. Novartis Media Release. New data demonstrate benefits of once-yearly Aclasta in the treatment of postmenopausal osteoporosis. September 16, 2006. Available at: http://cws.huginonline.com/N/134323/PR/200609/1075407_5.html. Accessed September 22, 2006
  51. Kademani D, Koka S, Lacy MQ, et al. Primary surgical therapy for osteonecrosis of the jaw secondary to bisphosphonate therapy. Mayo Clin Proc. 2006;81:1100
  52. Chhoeu AH, Siegel D, Landesberg R, et al. A case series of hyperbaric oxygen treatment for non-radiation induced osteonecrosis of the jaw. J Oral Maxillofac Surg. 2006;64(suppl):80
  53. National Institutes of Health Program Announcement. Available at: http://grants2.nih.gov/grants/guide/pa-files/PA-06-500.html. Accessed September 15, 2006
  54. National Institutes of Health Computer Retrieval of Information on Scientific Projects. Available at: http://crisp.cit.nih.gov/crisp/CRISP_LIB.getdoc?textkey=7145967&p_grant_num=1R21DE017164-01A1&p_query=(osteonecrosis)&ticket=24536900&p_audit_session_id=133450496&p_audit_score=33&p_audit_numfound=2&p_keywords=osteonecrosis. Accessed September 14, 2006

 Disclaimer: The AAOMS is providing this position paper on Bisphosphonate-Related Osteonecrosis of the Jaw (BRONJ) to inform practitioners, patients, and other interested parties. The position paper is based on a review of the existing literature and the clinical observations of an expert Task Force composed of oral and maxillofacial surgeons experienced in the diagnosis, surgical and adjunctive treatment of diseases, injuries and defects involving both the functional and esthetic aspects of the hard and soft tissues of the oral and maxillofacial regions, epidemiologists, and basic researchers. The position paper is informational in nature and is not intended to set any standards of care. AAOMS cautions all readers that the strategies described in the position paper are not practice parameters or guidelines and may not be suitable for every, or any, purpose or application. This position paper cannot substitute for the individual judgment brought to each clinical situation by the patient’s oral and maxillofacial surgeon. As with all clinical materials, the position paper reflects the science related to BRONJ at the time of the paper’s development, and it should be used with the clear understanding that continued research and practice may result in new knowledge or recommendations. AAOMS makes no express or implied warranty regarding the accuracy, content, completeness, reliability, operability, or legality of information contained within the position paper, including, without limitation, the warranties of merchantability, fitness for a particular purpose, and noninfringement of proprietary rights. In no event shall the AAOMS be liable to the user of the position paper or anyone else for any decision made or action taken by him or her in reliance on such information.

PII: S0278-2391(06)01979-3

doi: 10.1016/j.joms.2006.11.003

Journal of Oral and Maxillofacial Surgery
Volume 65, Issue 3 , Pages 369-376 , March 2007