American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws—2009 Update

Ruggiero, Salvatore L.; Dodson, Thomas B.; Assael, Leon A.; Landesberg, Regina; Marx, Robert E.; Mehrotra, Bhoomi

doi:10.1016/j.joms.2009.01.009

Cited by 817 publications

(1,099 citation statements)

References 59 publications

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“…15,16 In addition, a transient early stage of bisphosphonate-associated osteonecrosis of the jaws described as nonexposed variant was included in recent classifications. [21][22][23] The present case series differs from previous reports because abnormal radiological findings were not considered a necessary diagnostic criterion for bisphosphonate-associated osteonecrosis of the jaws and the nonexposed variant proved to be a separate entity per se in approximately 50% of patients. However, we cannot draw firm conclusions as it cannot be excluded that frank bone exposure would occur at a later time following the onset of nonexposed osteonecrosis.…”

Section: Discussioncontrasting

confidence: 64%

Nonexposed Variant of Bisphosphonate-associated Osteonecrosis of the Jaw: A Case Series

Fedele

Porter

D’Aiuto

et al. 2010

The American Journal of Medicine

213

149

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PURPOSE:To report a case series of patients with the nonexposed variant of bisphosphonate-associated osteonecrosis of the jaw-a form of jaw osteonecrosis that does not manifest with necrotic bone exposure/ mucosal fenestration. METHODS: Among 332 individuals referred to 5 clinical centers in Europe because of development of jawbone abnormalities after or during exposure to bisphosphonates, we identified a total of 96 patients who presented with the nonexposed variant of osteonecrosis. Relevant data were obtained via clinical notes; radiological investigations; patients' history, and referral letters. RESULTS:The most common clinical feature of nonexposed osteonecrosis was jaw bone pain (88/96; 91.6%); followed by sinus tract (51%), bone enlargement (36.4%); and gingival swelling (17.7%). No radiological abnormalities were identified in 29.1% (28/96) of patients. In 53.1% (51/96) of the patients; nonexposed osteonecrosis subsequently evolved into frank bone exposure within 4.6 months (mean; 95% confidence interval; 3.6-5.6). CONCLUSIONS: Clinicians should be highly vigilant to identify individuals with nonexposed osteonecrosis, as the impact on epidemiological data and clinical trial design could be potentially significant. Although the present case series represents approximately 30% of all patients with bisphosphonates-associated osteonecrosis observed at the study centers, further population-based prospective studies are needed to obtain robust epidemiological figures.

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Section: Discussioncontrasting

confidence: 64%

Nonexposed Variant of Bisphosphonate-associated Osteonecrosis of the Jaw: A Case Series

Fedele

Porter

D’Aiuto

et al. 2010

The American Journal of Medicine

213

149

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“…Hyperbaric oxygen (HBO) has been proposed 7 but it cannot be recommended as the sole treatment 8 . Recently the use of platelet-rich plasma has been reported to have potential for the prevention and treatment of MRONJ, as shown by Mozzati et al 9,10 .…”

Section: Resultsmentioning

confidence: 99%

Treatment of biphosphonate-related osteonecrosis of the jaw (BRONJ) combining surgical resection and PRGF®-Endoret® and rehabilitation with dental implants: Case report

Anitua¹

2017

Balkan J Dent Med

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“…In 2009, the AAOMS Task Force updated its recommendations on BRONJ [13] by adding the Bstage 0^to classify patients presenting with a number of oral signs and symptoms other than bone exposure but, unfortunately, they did not modify the 2007 definition. The contradictory nature of the position paper was then underlined by several authors and researchers, claiming for a broader definition to include the Bnon-exposedÔ NJ variant [14,15].…”

Section: To the Editormentioning

confidence: 99%

Definition and estimation of osteonecrosis of jaw (ONJ), and optimal duration of antiresorptive treatment in bone metastatic cancer patients: supplementary data from the denosumab extension study?

Fusco

Bedogni

Addeo

et al. 2016

Support Care Cancer

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To the Editor,In their recent article, Stopeck et al. [1] concluded that denosumab confirms its known safety profile even after longterm exposure, or after switching to it from zoledronic acid, and that osteonecrosis of jaws (ONJ) rates increased with increasing exposure to antiresorptives, consistent with previous reports. This is based on the open label extension phase of two phase 3 studies in patients with breast and prostate cancer with bone metastases who were randomized to receive denosumab or zoledronic acid (ZA) [2,3]. The patients were offered open-label denosumab for up to an additional 2 years after the results of the primary analysis, favorable for denosumab on several aspects. Patients initially randomized to denosumab (denosumab/ denosumab group) continued to receive denosumab at 120 mg Q4W whereas patients on ZA were switched to denosumab in the open-label phase (ZA/denosumab group) at 120 mg Q4W starting 4 weeks from their last ZA dose. Patients who declined further therapy in the open-label extension phase, or who did not complete the blinded treatment phase, continued follow-up for survival every 12 weeks (Q12W) for up to 2 years after their last dose.We collected data from the text and the tables of the paper published by Stopeck et al. [1] and summarized them in a new table (Table 1).Although authors' conclusions are quite reassuring both in terms of denosumab safety and efficacy, it is noteworthy that the median exposure of patients to denosumab in the extension phase study is lower than expected, even in the presence of a longer range. The final median exposure of the 318 denosumab/denosumab breast cancer patients is 19.1 months (range 0.1-59.8), not much longer than that registered for the whole cohort of the 1019 breast cancer patient population enrolled in the blinded phase, that was 17.6 months (range 0-23.7). As far as prostate cancer patients are concerned, the median denosumab exposure was 12.0 months (range 0.1-67.2) for the 147 denosumab/denosumab patients from the extension study versus 12.0 months (range 0.1-23.3) for the 942 patients enrolled in the original randomized trial. We could not work out from the paper the median denosumab exposure for 318 breast and 147 prostate cancer patients of the extension study denosumab/denosumab population in the previous blinded phase. This appears to us a weakness of the article.Interestingly, the frequency of ONJ cases in the open label extension study appears substantially higher than what is found in the initial blinded phase (ONJ frequency ranging from 1 to 2 %) [2, 3] despite median denosumab exposure was not significantly longer in the former. The crude ONJ figures increased both in denosumab/denosumab groups and in ZA/denosumab populations: ONJ cases were respectively 20/318 (6.3 %) in breast patients and 12/147 (8.2 %) in prostate patients in the denosumab/denosumab group, whereas they were 18/334 (5.4 %) breast patients and 7/118 (5.9 %) prostate patients in the ZA/denosumab group.Such an increase in ONJ frequency highlights the ne...

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American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws—2009 Update

Cited by 817 publications

References 59 publications

Nonexposed Variant of Bisphosphonate-associated Osteonecrosis of the Jaw: A Case Series

Nonexposed Variant of Bisphosphonate-associated Osteonecrosis of the Jaw: A Case Series

Treatment of biphosphonate-related osteonecrosis of the jaw (BRONJ) combining surgical resection and PRGF®-Endoret® and rehabilitation with dental implants: Case report

Definition and estimation of osteonecrosis of jaw (ONJ), and optimal duration of antiresorptive treatment in bone metastatic cancer patients: supplementary data from the denosumab extension study?

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