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Risedronate on Two Consecutive Days per Month

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Abstract

  • ▲ Risedronate, an orally administered pyridinal bisphosphonate, is effective in the treatment and prevention of postmenopausal osteoporosis. Efforts to optimize patient adherence and persistence with, and hence the effectiveness of, therapy have led to the development of a 75 mg tablet to be taken on two consecutive days each month (2CDM).

  • ▲ After 1 year of treatment, risedronate 75 mg 2CDM was noninferior to risedronate 5 mg once daily in improving lumbar spine bone mineral density (BMD) in an ongoing (2-year) randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.4% and 3.6% in the 75mg 2CDM and 5mg once-daily groups; the upper limit of the 95% confidence interval for the treatment difference (5mg once daily — 75 mg 2CDM; −0.19%, 0.62%) did not exceed the predefined noninferiority margin (1.5%).

  • ▲ In general, improvements in hip BMD and reductions in bone turnover markers with the 75 mg 2CDM regimen were not significantly different from those with the 5mg once-daily regimen; there was no significant between-group difference in the incidence of new vertebral fractures at 12 months.

  • ▲ The tolerability profile (including the incidence of upper gastrointestinal tract adverse events) of risedronate 75 mg 2CDM in postmenopausal women with osteoporosis was similar to that of risedronate 5 mg once daily.

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References

  1. National Osteoporosis Foundation. Fast facts on osteoporosis [online]. Available from URL: http://www.nof.org/osteoporosis/diseasefacts.htm [Accessed 2009 Apr 20]

  2. International Osteoporosis Foundation. Facts and statistics about osteoporosis and its impact [online]. Available from URL: http://www.iofbonehealth.org/facts-and-statistics.html [Accessed 2009 Apr 20]

  3. Gardner MJ, Demetrakopoulos D, Shindle MK, et al. Osteoporosis and skeletal fractures. HSS J 2006 Feb; 2(1): 62–9

    Article  PubMed  Google Scholar 

  4. North American Menopause Society. Management of postmenopausal osteoporosis: position statement of the North American Menopause Society. Menopause 2002 Mar; 9(2): 84–101

    Google Scholar 

  5. The Merck Manual Online. Osteoporosis [online]. Available from URL: http://www.merck.com/mmpe/sec04/ch036/ch036a.html [Accessed 2009 Apr 20]

  6. Bilezikian JP. Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis. Am J Med 2009 Feb; 122(2 Suppl.): S14–21

    Article  PubMed  CAS  Google Scholar 

  7. Bock O, Felsenberg D. Bisphosphonates in the management of postmenopausal osteoporosis-optimizing efficacy in clinical practice. Clin Interv Aging 2008; 3(2): 279–97

    PubMed  CAS  Google Scholar 

  8. Adami S. Bisphosphonate antifracture efficacy. Bone 2007; 41 (5 Suppl. 1): S8–15

    Article  CAS  Google Scholar 

  9. Emkey RD, Ettinger M. Improving compliance and persistence with bisphosphonate therapy for osteoporosis. Am J Med 2006 Apr; 119 (4 Suppl. 1): S18–24

    Article  PubMed  Google Scholar 

  10. Moro-Alvarez MJ, Diaz-Curiel M. Risedronate once monthly: a potential new regimen for the treatment of postmenopausal osteoporosis. Clin Interv Aging 2008; 3(2): 227–32

    PubMed  CAS  Google Scholar 

  11. Brandi ML. New dosing options in osteoporosis treatment: clinical evidence on risedronate 75 mg monthly treatment. Clin Case Min Bone Metab 2008; 5(2): 155–8

    Google Scholar 

  12. Lewiecki EM. Long dosing intervals in the treatment of postmenopausal osteoporosis. Curr Med Res Opin 2007 Nov; 23(11): 2617–25

    Article  PubMed  CAS  Google Scholar 

  13. White NJ, Perry CM. Risedronate once a week. Treat Endocrinol 2003; 2(6): 415–20

    Article  PubMed  CAS  Google Scholar 

  14. Wells G, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2006; (1): CD004523

    Google Scholar 

  15. Russell RG. Bisphosphonates: mode of action and pharmacology. Pediatrics 2007 Mar; 119Suppl. 2: S150–62

    Article  PubMed  Google Scholar 

  16. Kimmel DB. Mechanism of action, pharmacokinetic and pharmacodynamic profile, and clinical applications of nitrogen-containing bisphosphonates. J Dent Res 2007 Nov; 86(11): 1022–33

    Article  PubMed  CAS  Google Scholar 

  17. Russell RG, Watts NB, Ebetino FH, et al. Mechanisms of action of bisphosphonates: similarities and differences and their potential influence on clinical efficacy. Osteoporos Int 2008 Jun; 19(6): 732–59

    Article  Google Scholar 

  18. Thompson GA, Schnell DJS, Russell DA, et al. A monthly dosing regimen of risedronate reduces bone turnover similar to daily administration [abstract no. F363]. J Bone Miner Res 2006 Sep; 21Suppl. 1: S111

    Google Scholar 

  19. Delmas PD, Benhamou CL, Man Z, et al. Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results. Osteoporos Int 2008 Jul; 19(7): 1039–45

    Article  PubMed  CAS  Google Scholar 

  20. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA 1999 Oct 13; 282(14): 1344–52

    Article  PubMed  CAS  Google Scholar 

  21. Eriksen EF, Melsen F, Sod E, et al. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002 Nov; 31(5): 620–5

    Article  PubMed  CAS  Google Scholar 

  22. Mellstrom DD, Sorensen OH, Goemaere S, et al. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 2004 Dec; 75(6): 462–8

    Article  PubMed  CAS  Google Scholar 

  23. Thompson GA, Russell DA, Schnell DJ, et al. Risedronate pharmacokinetics following daily and monthly dosing regimens [abstract no. SU336]. J Bone Min Res 2006 Sep; 21Suppl. 1: S162

    Google Scholar 

  24. Mitchell DY, Eusebio RA, Dunlap LE, et al. Risedronate gastrointestinal absorption is independent of site and rate of administration. Pharm Res 1998; 15: 228–32

    Article  PubMed  CAS  Google Scholar 

  25. Actonel® (risedronate sodium) tablets. Prescribing information. Bridgewater (NJ): Sanofi-Aventis US, 2008 Apr

  26. Mitchell DY, Eusebio RA, Sacco-Gibson NA, et al. Doseproportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers. J Clin Pharmacol 2000 Mar; 40(3): 258–65

    Article  PubMed  CAS  Google Scholar 

  27. Mitchell DY, Heise MA, Pallone KA, et al. The effect of dosing regimen on the pharmacokinetics of risedronate. Br J Clin Pharmacol 1999 Oct; 48(4): 536–42

    Article  PubMed  CAS  Google Scholar 

  28. Mitchell DY, Barr WH, Eusebio RA, et al. Risedronate pharmacokinetics and intra- and inter-subject variability upon single-dose intravenous and oral administration. Pharm Res 2001 Feb; 18(2): 166–70

    Article  PubMed  CAS  Google Scholar 

  29. Dunn CJ, Goa KL. Risedronate: a review of its pharmacological properties and clinical use in resorptive bone disease. Drugs 2001; 61(5): 685–712

    Article  PubMed  CAS  Google Scholar 

  30. Mitchell DY, St Peter JV, Eusebio RA, et al. Effect of renal function on risedronate pharmacokinetics after a single oral dose. Br J Clin Pharmacol 2000 Mar; 49(3): 215–22

    Article  PubMed  CAS  Google Scholar 

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Acknowledgements and Disclosures

The manuscript was reviewed by: S. Adami, Rheumatology Department, University of Verona, Verona, Italy; and G. Bianchi, Division of Rheumatology, Azienda Sanitaria Genovese, Genoa, Italy.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Wolters Kluwer Health | Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    James E. Frampton

  2. Wolters Kluwer Health, Philadelphia, Pennsylvania, USA

    James E. Frampton

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Correspondence to James E. Frampton.

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Frampton, J.E. Risedronate on Two Consecutive Days per Month. Drugs Aging 26, 355–362 (2009). https://doi.org/10.2165/00002512-200926040-00006

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