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Drug Safety
Published in: Drug Safety 1/2018

01-01-2018 | Original Research Article

Treatment of Medication-Related Osteonecrosis of the Jaw and its Impact on a Patient’s Quality of Life: A Single-Center, 10-Year Experience from Southern Italy

Authors: Giacomo Oteri, Gianluca Trifirò, Matteo Peditto, Loredana Lo Presti, Ilaria Marcianò, Francesco Giorgianni, Janet Sultana, Antonia Marcianò

Published in: Drug Safety | Issue 1/2018

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Abstract

Introduction

No official guidelines are available for the management of medication-related osteonecrosis of the jaw (MR-ONJ). The additional benefit of surgery after pharmacological treatment is debated by both clinicians and patients.

Objective

The aim of this study was to evaluate the changes in patients’ MR-ONJ-related quality of life (QoL) after pharmacological treatment with or without surgery in a large cohort affected by MR-ONJ.

Methods

Anonymized data on patients diagnosed with MR-ONJ were extracted from the database of the Osteonecrosis of the Jaw Treatment Center (University of Messina, Italy) in the years 2005–2015. QoL was evaluated at the moment of MR-ONJ diagnoses (T0), after pharmacological treatment with or without surgery (T1 and T2, respectively), based on scores from the European Organisation for Research and Treatment of Cancer (EORTC) QOL Module for Head and Neck Cancer (global oral health status [GOHS]) and a visual analog scale (VAS), stratified by indication for use.

Results

Among 100 patients, 36% were affected by osteoporosis (OSTEO group) and 64% were affected by cancer (ONC group). Considering T0, QoL scores were higher in the OSTEO group then in the ONC group. At T1, GOHS and VAS increased in both groups (OSTEO group: +9.9% and +39.9%; ONC group: +35.4 and +97.2%, respectively). Pharmacological treatment was effective in reducing pain (OSTEO group: −22.0%; ONC group: −44.8%), and social contact troubles (OSTEO group: −40.3%; ONC group: −26.7%). At T2, GOHS and VAS further increased. Scores related to ‘pain’ and the troubles related to the ‘social dimension’ also decreased (OSTEO group: −91.3% and −72.0%; ONC group: 50.8% and −16.4%, respectively).

Conclusions

MR-ONJ-related QoL increased after pharmacological treatment and, more notably, after surgery, which may offer benefits to selected patients. QoL data may help clinicians in promoting tailored management of MR-ONJ.
Literature
1.
Hoff AO, Toth BB, Altundag K, et al. Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates. J Bone Min Res. 2008;23(6):826–36.CrossRef
2.
Fusco V, Porta C, Saia G, et al. A osteonecrosis of the jaw in patients with metastatic renal cell cancer treated with bisphosphonates and targeted agents: results of an italian multicenter study and review of the literature. Clin Genitourin Cancer. 2015;13(4):287–94.CrossRefPubMed
3.
Ruggiero SL, Dodson TB, Fantasia J, et al. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw-2014 update. American Association of Oral and Maxillofacial Surgeons. J Oral Maxillofac Surg. 2014;72(10):1938–56.CrossRefPubMed
4.
Voss PJ, Joshi Oshero J, Kovalova-Müller A, et al. Surgical treatment of bisphosphonate-associated osteonecrosis of the jaw: technical report and follow up of 21 patients. J Craniomaxillofac Surg. 2012;40(8):719–25.CrossRefPubMed
5.
Stockmann P, Burger M, von Wilmowsky C, et al. The outcome after surgical therapy of bisphosphonate-associated osteonecrosis of the jaw—results of a clinical case series with an average follow-up of 20 months. Clin Oral Investig. 2014;18(4):1299–304.PubMed
6.
Stanton DC, Balasanian E. Outcome of surgical management of bisphosphonate-related osteonecrosis of the jaws: review of 33 surgical cases. J Oral Maxillofac Surg. 2009;67(5):943–50.CrossRefPubMed
7.
Carlson ER, Basile JD. The role of surgical resection in the management of bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2009;67(5 Suppl):85–95.CrossRefPubMed
8.
Wilde F, Heufelder M, Winter K, et al. The role of surgical therapy in the management of intravenous bisphosphonates-related osteonecrosis of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011;111(2):153–63.CrossRefPubMed
9.
Graziani F, Vescovi P, Campisi G, et al. Resective surgical approach shows a high performance in the management of advanced cases of bisphosphonate-related osteonecrosis of the jaws: a retrospective survey of 347 cases. J Oral Maxillofac Surg. 2012;70(11):2501–7.CrossRefPubMed
10.
Miksad RA, Lai KC, Dodson TB, et al. Quality of life implications of bisphosphonate-associated osteonecrosis of the jaw. Oncologist. 2011;16(1):121–32.CrossRefPubMedPubMedCentral
11.
Kyrgidis A, Triaridis S, Kontos K, et al. Quality of life in breast cancer patients with bisphosphonate-related osteonecrosis of the jaws and patients with head and neck cancer: a comparative study using the EORTC QLQ-C30 and QLQ-HN35 questionnaires. Anticancer Res. 2012;32(8):3527–34.PubMed
12.
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organisation for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRefPubMed
13.
Oteri G, Bramanti E, Nigrone V, et al. Decayed, Missing, and Filled Teeth Index and periodontal health in osteoporotic patients affected by BRONJ: an observational study. J Osteoporos. 2013;2013:231289.CrossRefPubMedPubMedCentral
14.
Cutress TW, Ainamo J, Sardo-Infirri J. The community periodontal index of treatment needs (CPITN) procedure for population groups and individuals. Int Dent J. 1987;37(4):222–33.PubMed
15.
Bedogni A, Fedele S, Bedogni G, et al. Staging of osteonecrosis of the jaw requires computed tomography for accurate definition of the extent of bony disease. Br J Oral Maxillofac Surg. 2014;52(7):603–8.CrossRefPubMed
16.
Fedele S, Bedogni G, Scoletta M, et al. Up to a quarter of patients with osteonecrosis of the jaw associated with antiresorptive agents remain undiagnosed. Br J Oral Maxillofac Surg. 2015;53(1):13–7.CrossRefPubMed
17.
Epstein JB, Hong C, Logan RM, et al. A systematic review of orofacial pain in patients receiving cancer therapy. Support Care Cancer. 2010;18(8):1023–31.CrossRefPubMed
18.
Task Force on Bisphosphonate-Related Osteonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaw—update. Aust Endod J. 2009;2009(35):119–30.
19.
Watters AL, Hansen HJ, Williams T, et al. Intravenous bisphosphonate-related osteonecrosis of the jaw: long-term follow-up of 109 patients. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013;115(2):192–200.CrossRefPubMed
20.
Saad F, Brown JE, Van Poznak C, et al. Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases. Ann Oncol. 2012;23(5):1341.CrossRefPubMed
21.
Hoefert S, Eufinger H. Relevance of a prolonged preoperative antibiotic regime in the treatment of bisphosphonate-related osteonecrosis of the jaw. J Oral Maxillofac Surg. 2011;69(2):362–80.CrossRefPubMed
22.
Singer S, Arraras JI, Chie WC, et al. Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients EORTC QLQ-H&N35: a methodological review. Qual Life Res. 2013;22(8):1927–41.CrossRefPubMed
23.
Ohrn KE, Wahlin YB, Sjoden PO. Oral status during radiotherapy and chemotherapy: a descriptive study of patient experiences and the occurrence of oral complications. Support Care Cancer. 2001;9(4):247–57.CrossRefPubMed
24.
25.
Bodem JP, Schaal C, Kargus S, et al. Surgical management of bisphosphonate-related osteonecrosis of the jaw stages II and III. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016;121(4):367–72.CrossRefPubMed
26.
27.
Ibrahim A, Scher N, Williams G, et al. Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. Clin Cancer Res. 2003;9(7):2394–9.PubMed
28.
Kanis JA, McCloskey EV. Johansson H, on behalf of the Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013;24(1):23–57.CrossRefPubMed
29.
Yamazaki T, Yamori M, Ishizaki T, et al. Increased incidence of osteonecrosis of the jaw after tooth extraction in patients treated with bisphosphonates: a cohort study. Int J Oral Maxillofac Surg. 2012;41(11):1397–403.CrossRefPubMed
30.
Reid IR, Bolland MJ, Grey AB. Is bisphosphonate-associated osteonecrosis of the jaw caused by soft tissue toxicity? Bone. 2007;41:318–20.CrossRefPubMed
31.
Gelskey SC. Cigarette smoking and periodontitis: methodology to assess the strength of evidence in support of a causal association. Community Dent Oral Epidemiol. 1999;27:16–24.CrossRefPubMed
32.
Ricciardi GR, Russo A, Franchina T, et al. Efficacy of nab-paclitaxel plus trastuzumab in a long-surviving heavily pretreated HER2-positive breast cancer patient with brain metastases. Onco Targets Ther. 2015;8:289–94.PubMedPubMedCentral
33.
Geerse OP, Wynia K, Kruijer M, et al. Health-related problems in adult cancer survivors: development and validation of the Cancer Survivor Core Set. Support Care Cancer. 2017;25(2):567–74.CrossRefPubMed
34.
Wang EP, Kaban LB, Strewler GJ, et al. Incidence of osteonecrosis of the jaw in patients with multiple myeloma and breast or prostate cancer on intravenous bisphosphonate therapy. J Oral Maxillofac Surg. 2007;65(7):1328–31.CrossRefPubMed
35.
Migliorati CA. Intravenous bisphosphonate therapy may lead to osteonecrosis of the jaw in multiple myeloma, breast, and prostate cancer patients. J Evid Based Dent Pract. 2008;8(2):93–4.CrossRefPubMed
36.
Diab DL, Watts NB. Bisphosphonates in the treatment of osteoporosis. Endocrinol Metab Clin North Am. 2012;41(3):487–506.CrossRefPubMed
37.
Sánchez A, Blanco R. Osteonecrosis of the jaw (ONJ) and atypical femoral fracture (AFF) in an osteoporotic patient chronically treated with bisphosphonates. Osteoporos Int. 2017;28(3):1145–7.CrossRefPubMed
38.
Vandone AM, Donadio M, Mozzati M, et al. Impact of dental care in the prevention of bisphosphonate-associated osteonecrosis of the jaw: a single-center clinical experience. Ann Oncol. 2012;23:193–200.CrossRefPubMed
39.
Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009;67(5 Suppl):61–70.CrossRefPubMed
40.
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(34):8580–7.CrossRefPubMed
41.
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 Pathol Oral Radiol Endod. 2006;102(4):433–41.CrossRefPubMed
42.
Kos M, Junka A, Smutnicka D, et al. Pamidronate enhances bacterial adhesion to bone hydroxyapatite. Another puzzle in the pathology of bisphosphonate-related osteonecrosis of the jaw? J Oral Maxillofac Surg. 2013;71(6):1010–6.CrossRefPubMed
43.
Qi WX, Tang LN, He AN, et al. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014;19(2):403–10.CrossRefPubMed
44.
Grbic JT, Black DM, Lyles KW, et al. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010;141(11):1365–70.CrossRefPubMed
45.
Papapoulos S, Chapurlat R, Libanati C, et al. Five years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extension. J Bone Miner Res. 2012;27(3):694–701.CrossRefPubMed
46.
Lo JC, O’Ryan FS, Gordon NP, et al. Prevalence of osteonecrosis of the jaw in patients with oral bisphosphonate exposure. J Oral Maxillofac Surg. 2010;68(2):243–53.CrossRefPubMed
47.
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.CrossRefPubMed
48.
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.CrossRefPubMed
49.
Guarneri V, Miles D, Robert N, et al. Bevacizumab and osteonecrosis of the jaw: incidence and association with bisphosphonate therapy in three large prospective trials in advanced breast cancer. Breast Cancer Res Treat. 2010;122(1):181–8.CrossRefPubMed
50.
Fusco V, Santini D, Armento G, et al. Osteonecrosis of jaw beyond antiresorptive (bone-targeted) agents: new horizons in oncology. Expert Opin Drug Saf. 2016;15(7):925–35.CrossRefPubMed
51.
Metadata
Title
Treatment of Medication-Related Osteonecrosis of the Jaw and its Impact on a Patient’s Quality of Life: A Single-Center, 10-Year Experience from Southern Italy
Authors
Giacomo Oteri
Gianluca Trifirò
Matteo Peditto
Loredana Lo Presti
Ilaria Marcianò
Francesco Giorgianni
Janet Sultana
Antonia Marcianò
Publication date
01-01-2018
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 1/2018
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-017-0582-6

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