Basic and patient-oriented research
Nature and Frequency of Bisphosphonate-Associated Osteonecrosis of the Jaws in Australia

https://doi.org/10.1016/j.joms.2006.10.061Get rights and content

Purpose

The purpose of this study is to estimate the frequency and describe the clinical characteristics of patients diagnosed with bisphosphonate-associated osteonecrosis of the jaws (ONJ) in Australia.

Materials and Methods

Cases of ONJ were identified in 2004 and 2005 primarily by a postal survey of Australian Oral and Maxillofacial Surgeons (OMS) with additional cases from other dental specialists and the Commonwealth of Australia Adverse Drug Reaction Committee (ADRAC). The clinical characteristics were recorded. The frequency of ONJ cases was estimated from prescription and dental extraction data. Univariate and bivariate statistics were calculated.

Results

One hundred fifty-eight cases of ONJ were identified. These were primarily in patients with bone malignancy (72%) and the main trigger was dental extraction (73%). The reported number of cases varied between different Australian States with the highest frequency being reported in the States with the best integrated health systems. The frequency of ONJ in osteoporotic patients, mainly on weekly oral alendronate was 1 in 2,260 to 8,470 (0.01% to 0.04%) patients. If extractions were carried out, the calculated frequency was 1 in 296 to 1,130 cases (0.09% to 0.34%). The total dose of oral alendronate at the onset of ONJ was 9,060 (±7,269) mg. The frequency of ONJ for Paget’s disease cases was 1 in 56 to 380 (0.26% to 1.8%). If extractions were carried out, the calculated frequency of ONJ was 1 in 7.4 to 48 (2.1% to 13.5%). The frequency of ONJ in bone malignancy cases, treated with mainly intravenous zoledronate or pamidronate was 1 in 87 to 114 (0.88% to 1.15%). If extractions were carried out, the calculated frequency of ONJ was 1 in 11 to 15 (6.67% to 9.1%) The total dose of pamidronate was 3,285 (±2,530) mg and zoledronate 62 (±54.28) mg at the onset of ONJ. The median time to onset of ONJ was 12 months for zoledronate, 24 months for pamidronate, and 24 months alendronate.

Conclusions

Before the prescription of bisphosphonates for bone disease the patient should be made dentally fit so that the need for subsequent dental extractions is minimized. Appropriate informed consent for the risk of ONJ for different bisphosphonates, for osteoporosis, and malignancy both in general and in particular for dental extractions can be provided using this data.

Section snippets

Materials and Methods

A 2-page survey form with a reply-paid envelope was sent to all of the Australian members of the Australian and New Zealand Association of Oral and Maxillofacial Surgeons (ANZAOMS). The cover letter indicated the reasons for the survey and gave recipients the options of not participating, simply giving the number of ONJ cases that they had treated, or providing details of the cases treated. A working definition of ONJ is an area of exposed bone in the jawbones that fails to heal within 6 weeks

Results

One hundred thirteen questionnaires were mailed to all of the clinically active members of ANZAOMS, with 94 (83%) responding. One hundred and three cases of ONJ were identified with completed questionnaires being provided for 78 cases. Many questionnaires were incomplete. Hence the variable n numbers reported in the tables. The survey was completed in September 2005. Only a few cases were reported to occur before September 2003, hence the study period was 2 years. A further 6 cases were

Discussion

This study shows that bisphosphonate-associated ONJ is a recent and severe condition in Australia. Given the increasing frequency of osteoporosis as the population of Australia progressively ages then the use of oral bisphosphonates is likely to increase. Similarly the bisphosphonates have been shown to be an effective drug in the management of bone malignancy. ONJ is an ongoing and probably increasing challenge that needs to be understood and strategies developed to prevent its occurrence.

The

Acknowledgments

The authors thank members of ANZAOMS for their assistance in responding to the questionnaire and to ADRAC for the data they generously shared. The statistical advice of Dr D. Brennan and Professor A.J. Spencer, The University of Adelaide, is acknowledged. The constructive criticism and assistance of multiple bone metabolic, oncology, pharmaceutical, and dental colleagues, both within Australia and globally, are acknowledged.

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