Health> Vol.5 No.7B, July 2013

Actonel® (risedronate) therapy for the maintenance of alveolar bone in adult chronic periodontitis

DownloadDownload as PDF (Size:198KB)  HTML    PP. 12-17  

ABSTRACT

Introduction: The primary objective of this study was to determine whether risedronate sodium (Actonel?) therapy, in conjunction with conventional non-surgical periodontal treatment, reduces the rate of alveolar bone loss. Secondary aims were to compare the incidence of patient dropouts in the risedronate and placebo groups, and to document adverse events. Methods: This double-blind randomized placebo-controlled trial was conducted in 125 patients with moderate to severe periodontitis. At baseline, three, and nine months, standardized vertical bite-wing radiographs were taken and used to measure bone loss. Clinical periodontal examinations were taken at three-month intervals to assess whether or not the patient was experiencing rapid periodontal breakdown, in which case suitable treatment could be planned and delivered. Patients received scaling and root planing at baseline and periodontal maintenance at three-month intervals thereafter. At three months, subjects were randomly assigned to risedronate (35 mg/week by mouth) or placebo in blocks based on the severity of periodontitis (moderate, mean bone loss 2 -4 mm; or severe, mean bone loss >4 mm); smoking; and diabetes. Interval bone loss in millimeters was measured from the radiographs, and analysis of variance (ANOVA) was used to test for differences in bone loss between test and placebo groups. Results: Over the nine-month study duration, the test group exhibited a significantly greater increase in bone height (0.31 ±0.09 mmgain test, 0.08 ±0.09 mmgain placebo, F = 4.94, p < 0.04). There were significantly fewer dropouts in the risedronate treated group (4.8%) than in the placebo treated group (17.5%; p < 0.04, Fisher Exact Test). No serious adverse events or cases of osteonecrosis of the jaw (ONJ) were observed. Conclusions: Periodontitis subjects treated with risedronate had significantly more bone gain compared to placebo treated subjects. Significantly more subjects from the placebo group dropped out, suggesting the possibility of a patient-noticeable effect. There was no indication of ONJ.

Cite this paper

Tanna, N. and Jeffcoat, M. (2013) Actonel® (risedronate) therapy for the maintenance of alveolar bone in adult chronic periodontitis. Health, 5, 12-17. doi: 10.4236/health.2013.57A2002.

References

[1] Jeffcoat, M.K., et al. (2005) Osteoporosis and oral bone loss: Current literature. Journal of Periodontology, 76, 2125-2132. doi:10.1902/jop.2005.76.11-S.2125
[2] Reddy, M.S., Weatherford, T.W.I., Smith, C.A., West, B. D., Jeffcoat, M.K. and Jacks, T.M. (1995) Alendronate treatment of naturally occurring periodontitis in beagles. Journal of Periodontology, 66, 211-217. doi:10.1902/jop.1995.66.3.211
[3] Brunsvold, M.A., Chaves, E.S., Kornman, K.S., Aufdemorte, T.B. and Wood, R. (1992) Effects of a bisphosphonate on experimental periodontitis in monkeys. Journal of Periodontology, 63, 825-830. doi:10.1902/jop.1992.63.10.825
[4] Lane, N., Armitage, G.C., Loomer, P., Hsieh, S., Majumdar, S., Wang, H.Y., Jeffcoat, M. and Munoz, T. (2005) Bisphosphonate therapy improves the outcome of conventional periodontal treatment: Results of a 12-month, randomized, placebo-controlled study. Journal of Periodontology, 76, 1113-1122. doi:10.1902/jop.2005.76.7.1113
[5] El-Shinnawi, U.M. and El-Tantawy, S.I. (2003) The effect of alendronate sodium on alveolar bone loss in periodontitis. Journal of the International Academy of Periodontology, 5, 5-10.
[6] Rocha, M., Nava, L.E., Vazquez de la Torre, C., Sanchez-Marin, F., Garay-Sevilla, M.E. and Malacara, J.M. (2001) Clinical and radiological improvement of periodontal disease in patients with type 2 diabetes mellitus treated with alendronate: A randomized, placebo-controlled trial. Journal of Periodontology, 72, 204-209. doi:10.1902/jop.2001.72.2.204
[7] Rocha, M.L., Malacara, J.M., Sánchez-Marin, F.J., Vazquez de la Torre, C.J. and Fajardo, M.E. (2004) Effect of alendronate on periodontal disease in postmenopausal women: A randomized placebo-controlled trial. Journal of Periodontology, 75, 1579-1585. doi:10.1902/jop.2004.75.12.1579
[8] Jeffcoat, M.K., Cizza, G., Shi, J., Genco, R. and Lombardi, A. (2007) Efficacy of bisphosphonates for the control of alveolar bone loss in periodontitis. Journal of the International Academy of Periodontology, 9, 70-76.
[9] Durie, B.G., Katz, M. and Crowley, J. (2005) Osteonecrosis of the jaw and bisphosphonates. New England Journal of Medicine, 353, 99-102. doi:10.1056/NEJM200507073530120
[10] Ruggiero, S.L. and Mehrotra, B. (2004) Ten years of alendronate treatment for osteoporosis in postmenopausal women. New England Journal of Medicine, 350, 1189-1199. doi:10.1056/NEJMoa030897
[11] Ruggiero, S.L., Mehrotra, B., Rosenberg, T.J. and Engroff, S.L. (2003) Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. Journal of Oral and Maxillofacial Surgery, 61, 1238-1239.
[12] Schwartz, H.C. (2004) Osteonecrosis and bisphosphonates: Correlation versus causation. Journal of Oral and Maxillofacial Surgery, 62, 763-764. doi:10.1016/j.joms.2004.03.005
[13] Piale, P.H.V. and Lin, A. (2005) Exposed bone in oral cavities. Clinical Journal of Oncology Nursing, 9, 355-357. doi:10.1188/05.CJON.355-357
[14] Badros, A., Weikel, D., Salama, A., Goloubeva, O. and Schneider, A., Rapoport, A., Fenton, R., Gahres, N., Sausville, E., Ord, R. and Meiller, T. (2006) Osteonecrosis of the jaw in multiple myeloma patients: Clinical features and risk factors. Journal of Clinical Oncology, 24, 45-52. doi:10.1200/JCO.2005.04.2465
[15] Farrugia, M.C., Summerlin, D.J., Krowiak, E., Huntley, T., Freeman, S., Borrowdale, R. and Tomich, C. (2006) Osteonecrosis of the mandible or maxilla associated with the use of new generation bisphosphonates. Laryngoscope, 116, 15-20. doi:10.1097/01.mlg.0000187398.51857.3c
[16] Markiewicz, M.R., Margarone, J.E., Campbell, J.H. and Aguirre, A. (2005) Bisphosphonate-associated osteonecrosis of the jaws: A review of current knowledge. The Journal of the American Dental Association, 136, 1669-1674.
[17] Jeffcoat, M.K. (2006) Safety of oral bisphosphonates: Controlled studies on alveolar bone. The International Journal of Oral & Maxillofacial Implants, 21, 349-353.
[18] Jeffcoat, M.K. (2011) Viewpoint on osteonecrosis of the jaw. Medscape.
[19] Rindal, J.L., Barasch, D.B., Gullion, A., Rush, C.M., Pihlstrom, D.J. and Richman, D.J. (DPBRN Collaborative Group) (2011) ONJ in two dental practice-based research network regions. Journal of Dental Research, 90, 433-438. doi:10.1177/0022034510387795
[20] Abrahamsen, B. (2010) Bisphosphonate adverse effects, lessons from large databases. Current Opinion in Rheumatology, 22, 404-409. doi:10.1097/BOR.0b013e32833ad677
[21] Skrepnek, G.H., Seal, B., Tangirala, M., Jeffcoat, M.K., Watts, N.B. and Hay, J.W. (2010) Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the US. General Dentistry, 58, 484-492.
[22] Pazianas, M., Russell, R.G. and Fogelman, I. (2009) Osteonecrosis of the jaw: More heat than light. Journal of Nuclear Medicine, 50, 6-7. doi:10.2967/jnumed.108.057885

comments powered by Disqus

Copyright © 2014 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.