Abstract
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▲ 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).
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▲ 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%).
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▲ 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.
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▲ 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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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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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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DOI: https://doi.org/10.2165/00002512-200926040-00006