Existing data sources for clinical epidemiology: Scandinavian cohort for osteonecrosis of the jaw – Work in progress and challenges

Clinical Epidemiology

Volumn 7, Issue , 2015, Pages 107-116

  Schiodt, Morten ^a   Wexell, Cecilia Larsson ^b,c   Herlofson, Bente Brokstad ^d   Giltvedt, Karen Marie ^d   Norholt, Sven Erik ^e   Ehrenstein, Vera ^f  

^a Rigshospitalet   (Denmark)

^b Section of Rheumatology   (Sweden)

^c SAHLGRENSKA ACADEMY AT UNIVERSITY OF GOTHENBURG   (Sweden)

^d UNIVERSITY OF OSLO   (Norway)

^e AARHUS UNIVERSITY   (Denmark)

^f AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Antiresorptive; Bisphosphonate; Cancer; Classification; Denosumab; Epidemiology; Jaws; ONJ; Osteonecrosis; Osteoporosis; Scandinavia

Indexed keywords

BEVACIZUMAB; DENOSUMAB; SUNITINIB; ZOLEDRONIC ACID;

ANGIOGENESIS; ARTICLE; COHORT ANALYSIS; DATA BASE; DENMARK; DISEASE SEVERITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; INCIDENCE; JAW OSTEONECROSIS; LARGE SCALE PRODUCTION; NORWAY; PATHOGENESIS; PATIENT CARE; PROSPECTIVE STUDY; RISK FACTOR; SWEDEN;

EID: 84921854304     PISSN: None     EISSN: 11791349     Source Type: Journal    
DOI: 10.2147/CLEP.S71796     Document Type: Article

References (52)

1. Marx RE. Pamidronate (aredia) and zoledronate (zometa) induced avascular necrosis of the jaws: A growing epidemic. J Oral Maxillofac Surg. 2003;61(9):1115-1117.
2. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. J Oral Maxillofac Surg. 2004;62(5):527-534.
3. Migliorati CA, Woo SB, Hewson I, et al. A systematic review of bisphosphonate osteonecrosis (BON) in cancer. Support Care Cancer. 2010; 18(8):1099-1106.
4. Smith MR, Saad F, Coleman R, et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: Results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012;379(9810): 39-46.
5. Kruger TB, Sharikabad MN, Herlofson BB. Bisphosphonate-related osteonecrosis of the jaw in four Nordic countries and an indication of under-reporting. Acta Odontol Scand. 2013;71(6):1386-1390.
6. Bergdahl J, Jarnbring F, Ehrenstein V, et al. Evaluation of an algorithm ascertaining cases of osteonecrosis of the jaw in the Swedish national patient register. Clin Epidemiol. 2013;5:1-7.
7. Gammelager H, Erichsen R, Antonsen S, et al. Positive predictive value of the International Classification of Diseases, 10th revision, codes to identify osteonecrosis of the jaw in patients with cancer. Cancer Epidemiol. 2012;36(4):381-383.
8. Gammelager H, Svaerke C, Noerholt SE, et al. Validity of an algorithm to identify osteonecrosis of the jaw in women with postmenopausal osteoporosis in the Danish national registry of patients. Clin Epidemiol. 2013;5:263-267.
9. 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):243-253.
10. Solomon DH, Mercer E, Woo SB, Avorn J, Schneeweiss S, Treister N. Defining the epidemiology of bisphosphonate-associated osteonecrosis of the jaw: Prior work and current challenges. Osteoporos Int. 2013;24(1):237-244.
11. Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American society for bone and mineral research. J Bone Miner Res. 2007;22(10): 1479-1491.
12. Fehm T, Beck V, Banys M, et al. Bisphosphonate-induced osteonecrosis of the jaw (ONJ): Incidence and risk factors in patients with breast cancer and gynecological malignancies. Gynecol Oncol. 2009;112(3): 605-609.
13. 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.
14. 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):1341-1347.
15. Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws; AAOMS. American association of oral and maxillofacial surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007;65(3):369-376.
16. Ruggiero SL, Dodson TB, Assael LA, Landesberg R, Marx RE, Mehrotra B. American association of oral and maxillofacial surgeons position paper on bisphosphonate-related osteonecrosis of the jaw - 2009 update. Aust Endod J. 2009;35(3):119-130.
17. Fedele S, Porter SR, D’Aiuto F, et al. Nonexposed variant of bisphosphonate-associated osteonecrosis of the jaw: A case series. Am J Med. 2010;123(11):1060-1064.
18. Bagan JV, Hens-Aumente E, Leopoldo-Rodado M, Poveda-Roda R, Bagan L. Bisphosphonate-related osteonecrosis of the jaws: Study of the staging system in a series of clinical cases. Oral Oncol. 2012;48(8): 753-757.
19. Schiodt M, Reibel J, Oturai P, Kofod T. Comparison of nonexposed and exposed bisphosphonate-induced osteonecrosis of the jaws: A retrospective analysis from the Copenhagen cohort and a proposal for an updated classification system. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;117(2):204-213.
20. Lazarovici TS, Yahalom R, Taicher S, Elad S, Hardan I, Yarom N. Bisphosphonate-related osteonecrosis of the jaws: A single-center study of 101 patients. J Oral Maxillofac Surg. 2009;67(4): 850-855.
21. AAOMS. American Association of Oral and Maxillofacial Surgeons. Position paper on medication-related osteonecrosis of the jaw; 2014 [cited July 16, 2014]. Available from: http://www.aaoms.org/members/resources/aaoms-advocacy-and-position-statements/.
22. Fedele S, Bedogni G, Scolettea M, et al. Up to a quater of patients with osteonecrosis of the jaw associated with antiresorptive agents remain undiagnosed. Br J Oral & Maxillofac Surg. Epub October 1, 2014.
23. Itzstein C, Coxon FP, Rogers MJ. The regulation of osteoclast function and bone resorption by small GTPases. Small GTPases. 2011;2(3): 117-130.
24. Lacey DL, Boyle WJ, Simonet WS, et al. Bench to bedside: Elucidation of the OPG-RANK-RANKL pathway and the development of denosumab. Nat Rev Drug Discov. 2012;11(5):401-419.
25. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: A randomised, double-blind study. Lancet. 2011; 377(9768):813-822.
26. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125-1132.
27. Recknor C, Czerwinski E, Bone HG, et al. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: A randomized open-label trial. Obstet Gynecol. 2013;121(6):1291-1299.
28. Schwarz P, Rasmussen AQ, Kvist TM, Andersen UB, Jorgensen NR. Paget’s disease of the bone after treatment with Denosumab: A case report. Bone. 2012;50(5):1023-1025.
29. Rizzoli R, Body JJ, Brandi ML, et al. Cancer-associated bone disease. Osteoporos Int. 2013;24(12):2929-2953.
30. Koch FP, Walter C, Hansen T, Jager E, Wagner W. Osteonecrosis of the jaw related to sunitinib. Oral Maxillofac Surg. 2011;15(1):63-66.
31. Fleissig Y, Regev E, Lehman H. Sunitinib related osteonecrosis of jaw: A case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2012;113(3):e1-e3.
32. Estilo CL, Fornier M, Farooki A, Carlson D, Bohle G IIIrd, Huryn JM. Osteonecrosis of the jaw related to bevacizumab. J Clin Oncol. 2008;26(24):4037-4038.
33. Greuter S, Schmid F, Ruhstaller T, Thuerlimann B. Bevacizumab-associated osteonecrosis of the jaw. Ann Oncol. 2008;19(12):2091-2092.
34. 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):181-188.
35. Hopp RN, Pucci J, Santos-Silva AR, Jorge J. Osteonecrosis after administration of intravitreous bevacizumab. J Oral Maxillofac Surg. 2012;70(3):632-635.
36. Katsenos S, Christophylakis C, Psathakis K. Osteonecrosis of the jaw in a patient with advanced non-small-cell lung cancer receiving bevacizumab. Arch Bronconeumol. 2012;48(6):218-219.
37. Serra E, Paolantonio M, Spoto G, Mastrangelo F, Tete S, Dolci M. Bevacizumab-related osteneocrosis of the jaw. Int J Immunopathol Pharmacol. 2009;22(4):1121-1123.
38. Bettini G, Blandamura S, Saia G, Bedogni A. Bevacizumab-related osteonecrosis of the mandible is a self-limiting disease process. BMJ Case Rep. 2012;22:2012.
39. Vahtsevanos K, Kyrgidis A, Verrou E, et al. Longitudinal cohort study of risk factors in cancer patients of bisphosphonate-related osteonecrosis of the jaw. J Clin Oncol. 2009;27(32):5356-5362.
40. Yamashita J, McCauley LK. Antiresorptives and osteonecrosis of the jaw. J Evid Based Dent Pract. 2012;12(3 Suppl):233-247.
41. Van den Wyngaert T, Delforge M, Doyen C, et al. Prospective observational study of treatment pattern, effectiveness and safety of zoledronic acid therapy beyond 24 months in patients with multiple myeloma or bone metastases from solid tumors. Support Care Cancer. 2013;21(12):3483-3490.
42. Brufsky AM, Sereika SM, Mathew A, Tomifumi O, Singh V, Rosenzweig M. Long-term treatment with intravenous bisphosphonates in metastatic breast cancer: A retrospective study. Breast J. 2013;19(5): 504-511.
43. Otto S, Schreyer C, Hafner S, et al. Bisphosphonate-related osteonecrosis of the jaws - characteristics, risk factors, clinical features, localization and impact on oncological treatment. J Craniomaxillofac Surg. 2012;40(4):303-309.
44. 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): 1397-1403.
45. Beuselinck B, Wolter P, Karadimou A, et al. Concomitant oral tyrosine kinase inhibitors and bisphosphonates in advanced renal cell carcinoma with bone metastases. Br J Cancer. 2012;107(10):1665-1671.
46. Raje N, Woo SB, Hande K, et al. Clinical, radiographic, and biochemical characterization of multiple myeloma patients with osteonecrosis of the jaw. Clin Cancer Res. 2008;14(8):2387-2395.
47. Sarasquete ME, Garcia-Sanz R, Marin L, et al. Bisphosphonate-related osteonecrosis of the jaw is associated with polymorphisms of the cytochrome P450 CYP2C8 in multiple myeloma: A genome-wide single nucleotide polymorphism analysis. Blood. 2008;112(7):2709-2712.
48. Otto S, Pautke C, Opelz C, et al. Osteonecrosis of the jaw: Effect of bisphosphonate type, local concentration, and acidic milieu on the pathomechanism. J Oral Maxillofac Surg. 2010;68(11):2837-2845.
49. Ulmner M, Jarnbring F, Torring O. Osteonecrosis of the jaw in Sweden associated with the oral use of bisphosphonate. J Oral Maxillofac Surg. 2013;72(1):76-82.
50. Statistics Denmark. 2014. Available from: http://www.dst.dk. Accessed September 9, 2014.
51. Statistics Norway. 2014. Available from: http://www.ssb.no. Accessed September 9, 2014.
52. Statistics Sweden. 2014. Available from: http://www.scb.se. Accessed September 9, 2014.