AAOMS position paperAmerican Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws
Section snippets
Purpose
The purpose of this position paper is to provide:
- 1
Perspectives on the risk of developing BRONJ and the risks and benefits of bisphosphonates in order to facilitate medical decision-making of both the treating physician and the patient;
- 2
Guidance to clinicians regarding the differential diagnosis of BRONJ in patients with a history of treatment with intravenous (IV) or oral bisphosphonates; and
- 3
Guidance to clinicians on possible BRONJ prevention measures and management of patients with BRONJ based
Benefits of bisphosphonate therapy
Intravenous bisphosphonates are primarily used and effective in the treatment and management of cancer-related conditions. These include hypercalcemia of malignancy, skeletal-related events associated with bone metastases in the context of solid tumors such as breast cancer, prostate cancer, and lung cancer, and in the management of lytic lesions in the setting of multiple myeloma.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 The IV bisphosphonates are effective in preventing and reducing
BRONJ Case Definition
To distinguish BRONJ from other delayed healing conditions, the following working definition of BRONJ has been adopted by the AAOMS:
Patients may be considered to have BRONJ if all of the following 3 characteristics are present: 1) current or previous treatment with a bisphosphonate; 2) exposed, necrotic bone in the maxillofacial region that has persisted for more than 8 weeks; and 3) no history of radiation therapy to the jaws. It is important to understand that patients at risk for BRONJ or
IV bisphosphonates and incidence of BRONJ
The clinical efficacy of IV bisphosphonates for the treatment of hypercalcemia and bone metastases is well established.1, 2, 3, 4 Currently, available published incidence data for BRONJ are limited to retrospective studies with limited sample sizes. Based on these studies, estimates of the cumulative incidence of BRONJ range from 0.8% to 12%.34, 35, 36, 37, 38, 39, 40, 41, 42 With increased recognition, duration of exposure, and follow-up, it is likely that the incidence will rise.
Oral bisphosphonates and incidence of BRONJ
The clinical
Prevention of BRONJ
Prior to treatment with an IV bisphosphonate, the patient should have a thorough oral examination, any unsalvageable teeth should be removed, all invasive dental procedures should be completed, and optimal periodontal health should be achieved.
Based on the experience of 2 Task Force members with approximately 50 patients, the risk of developing BRONJ associated with oral bisphosphonates, although exceedingly small, appears to increase when the duration of therapy exceeds 3 years. This time
Staging
In order to direct rational treatment guidelines and collect data to assess the prognosis in patients who have used either IV or oral bisphosphonates, the AAOMS proposes use of the following staging categories:
- 1
Patients at risk: No apparent exposed/necrotic bone in patients who have been treated with either IV or oral bisphosphonates.
- 2
Patients with BRONJ
Stage 1: Exposed/necrotic bone in patients who are asymptomatic and have no evidence of infection.
Stage 2: Exposed/necrotic bone in patients with
Future Research
On July 31, 2006, the National Institutes of Health announced funding opportunities for research on the pathophysiology of bisphosphonate-associated osteonecrosis of the jaw.53 At least one grant has been awarded for a project titled “Bisphosphonates and Oral Complications of Cancer Chemotherapy: A Pilot Study,” with Dr Regina Landesberg as the principal investigator.54 Prospective clinical trials are required so that the present staging system can evolve into a more comprehensive staging
References (54)
- 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) Bisphosphonate treatment of osteoporosis
Clin Geriatr Med
(2003)- et al.
Alendronate increases lumbar spine bone mineral density in patients with Crohn’s disease
Gastroenterology
(2000) Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: A growing epidemic
J Oral Maxillofac Surg
(2003)- et al.
Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases
J Oral Maxillofac Surg
(2004) - et al.
Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: Risk factors, recognition, prevention and treatment
J Oral Maxillofac Surg
(2005) - et al.
Jaw osteonecrosis associated with bisphosphonates: Multiple exposed areas and its relationship to teeth extractionsStudy of 20 cases
Oral Oncol
(2006) - 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) - 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) - 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)
Osteonecrosis of the jaw associated with chroninc bisphosphonates therapy: An Italian experience
Blood (American Society of Hematology Annual Meeting Abstracts)
Bisphosphonates are associated with increased risk for jaw surgery in medical claims data: Is it osteonecrosis?
J Oral Maxillofac Surg
Bisphosphonate-related osteonecrosis of the jaw: Background and guidelines for diagnosis, staging and management
Oral Surg Oral Med Oral Path Oral Radiol Endod
Managing the care of patients with bisphosphonate-associated osteonecrosis
J Am Dent Assoc
Primary surgical therapy for osteonecrosis of the jaw secondary to bisphosphonate therapy
Mayo Clin Proc
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
Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases
N Engl J Med
Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate
J Clin Oncol
American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer
J Clin Oncol
A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma
J Natl Cancer Inst
Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer
J Natl Cancer Inst
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
Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma
N Engl J Med
Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events
J Clin Oncol
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
American Society of Clinical Oncology clinical practice guidelines: The role of bisphosphonates in multiple myeloma
J Clin Oncol
Physicians’ Desk Reference
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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.