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Efficacy and Safety of Monthly 150 mg Oral Ibandronate in Women with Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Lee, Young-Ho (Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine) ;
  • Song, Gwan-Gyu (Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine)
  • 발행 : 2011.09.01

초록

Background/Aims: The aim of this study was to assess the efficacy and safety of monthly oral 150 mg ibandronate in women with postmenopausal osteoporosis (PMO). Methods: A systematic review and meta-analysis were performed to determine treatment efficacy and safety outcomes between monthly oral 150 mg ibandronate and weekly 70 mg alendronate, daily 2.5 mg ibandronate, and a placebo. Results: Eight randomized controlled trials were included in this systematic review and meta-analysis. Once-monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, showing increased bone mineral density (BMD) in both the lumbar spine and total hip. Pooled data from two cross-over trials showed that significantly more women with PMO preferred once-monthly ibandronate therapy to once-weekly alendronate therapy (relative risk [RR], 2.422; 95% confidence interval [CI], 2.111 to 2.825; p < $1\;{\times}\;10^{-8}$) and found the monthly ibandronate regimen more convenient than the weekly alendronate regimen (RR, 3.096; 95% CI, 2.622 to 3.622; p < $1\;{\times}\;10^{-8}$). Monthly 150 mg ibandronate therapy resulted in a significantly higher change in BMD of the lumbar spine than with the placebo. A once monthly 150 mg regimen produced greater increases in lumbar spine, total hip, femoral neck, and trochanter BMD than daily treatment, with a similar incidence of adverse events between the groups. Conclusions: Once monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, and patients strongly preferred the convenience of monthly ibandronate over weekly alendronate. Monthly 150 mg ibandronate was superior to, and as well tolerated as, the daily treatment.

키워드

참고문헌

  1. Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 1993;94:646-650. https://doi.org/10.1016/0002-9343(93)90218-E
  2. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-1733. https://doi.org/10.1007/s00198-006-0172-4
  3. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-1733. https://doi.org/10.1007/s00198-006-0172-4
  4. Yood RA, Emani S, Reed JI, Lewis BE, Charpentier M, Lydick E. Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 2003;14:965-968. https://doi.org/10.1007/s00198-003-1502-4
  5. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-287. https://doi.org/10.1016/j.maturitas.2004.02.005
  6. Reginster JY, Felsenberg D, Cooper C, et al. A new concept for bisphosphonate therapy: a rationale for the development of monthly oral dosing of ibandronate. Osteoporos Int 2006;17:159-166. https://doi.org/10.1007/s00198-005-1957-6
  7. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin 2005;21:1453-1460. https://doi.org/10.1185/030079905X61875
  8. Kendler D, Kung AW, Fuleihan Gel-H, et al. Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. Maturitas 2004;48:243-251. https://doi.org/10.1016/j.maturitas.2003.12.012
  9. Barrett J, Worth E, Bauss F, Epstein S. Ibandronate: a clinical pharmacological and pharmacokinetic update. J Clin Pharmacol 2004;44:951-965. https://doi.org/10.1177/0091270004267594
  10. Frampton JE, Perry CM. Ibandronate: a review of its use in the management of postmenopausal osteoporosis. Drugs 2008;68:2683-2707. https://doi.org/10.2165/0003495-200868180-00011
  11. Rossini M, Viapiana O, Gatti D, Adami S. Once-monthly oral ibandronate in postmenopausal osteoporosis: translation and updated review. Clin Ther 2009;31:1497-1510. https://doi.org/10.1016/j.clinthera.2009.07.018
  12. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12. https://doi.org/10.1016/0197-2456(95)00134-4
  13. Davey Smith G, Egger M. Meta-analyses of randomised controlled trials. Lancet 1997;350:1182.
  14. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539-1558. https://doi.org/10.1002/sim.1186
  15. Emkey R, Delmas PD, Bolognese M, et al. Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study. Clin Ther 2009;31:751-761. https://doi.org/10.1016/j.clinthera.2009.04.018
  16. McClung MR, Bolognese MA, Sedarati F, Recker RR, Miller PD. Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. Bone 2009;44:418-422. https://doi.org/10.1016/j.bone.2008.09.011
  17. Lewiecki EM, Keaveny TM, Kopperdahl DL, et al. Once-monthly oral ibandronate improves biomechanical determinants of bone strength in women with postmenopausal osteoporosis. J Clin Endocrinol Metab 2009;94:171-180. https://doi.org/10.1210/jc.2008-1807
  18. Hadji P, Minne H, Pfeifer M, et al. Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: A randomized, crossover study (BALTO II). Joint Bone Spine 2008;75:303-310. https://doi.org/10.1016/j.jbspin.2007.07.011
  19. Miller PD, Epstein S, Sedarati F, Reginster JY. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study. Curr Med Res Opin 2008;24:207-213. https://doi.org/10.1185/030079908X253889
  20. Cooper A, Drake J, Brankin E; PERSIST Investigators. Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study. Int J Clin Pract 2006;60:896-905. https://doi.org/10.1111/j.1742-1241.2006.01059.x
  21. Emkey R, Koltun W, Beusterien K, et al. Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Curr Med Res Opin 2005;21:1895-1903. https://doi.org/10.1185/030079905X74862
  22. Reginster JY, Adami S, Lakatos P, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis 2006;65:654-661. https://doi.org/10.1136/ard.2005.044958
  23. Stakkestad JA, Lakatos P, Lorenc R, Sedarati F, Neate C, Reginster JY. Monthly oral ibandronate is effective and well tolerated after 3 years: the MOBILE long-term extension. Clin Rheumatol 2008;27:955-960. https://doi.org/10.1007/s10067-007-0824-6
  24. Miller PD, McClung MR, Macovei L, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 2005;20:1315-1322. https://doi.org/10.1359/JBMR.050313
  25. Reginster JY, Wilson KM, Dumont E, Bonvoisin B, Barrett J. Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study. J Clin Endocrinol Metab 2005;90:5018-5024. https://doi.org/10.1210/jc.2004-1750
  26. Epstein S, Jeglitsch M, McCloskey E. Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg. Curr Med Res Opin 2009;25:2951-2960. https://doi.org/10.1185/03007990903361307
  27. Harris ST, Blumentals WA, Miller PD. Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies. Curr Med Res Opin 2008;24:237-245. https://doi.org/10.1185/030079908X253717
  28. Pyon EY. Once-monthly ibandronate for postmenopausal osteoporosis: review of a new dosing regimen. Clin Ther 2006;28:475-490. https://doi.org/10.1016/j.clinthera.2006.04.006
  29. Sebba AI, Emkey RD, Kohles JD, Sambrook PN. Ibandronate dose response is associated with increases in bone mineral density and reductions in clinical fractures: results of a metaanalysis. Bone 2009;44:423-427. https://doi.org/10.1016/j.bone.2008.10.052

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