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Efficacy and safety of monthly oral minodronate in patients with involutional osteoporosis


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Title: Efficacy and safety of monthly oral minodronate in patients with involutional osteoporosis
Authors: Okazaki, Ryo / Hagino, Hiroshi / Ito, Masako / Sone, Teruki / Nakamura, Toshitaka / Mizunuma, Hideki / Fukunaga, Masao / Shiraki, Masataka / Nishizawa, Yoshiki / Ohashi, Yasuo / Matsumoto, Toshio
Issue Date: 1-Jun-2011
Publisher: Springer-Verlag
Citation: Osteoporosis International, 23(6), pp.1737-1745; 2012
Abstract: Summary Monthly minodronate at 30 or 50 mg had similar efficacy as 1 mg daily in terms of change in bone mineral density (BMD) and bone turnover markers with similar safety profiles. This new regimen provides patients with a new option for taking minodronate. Introduction Minodronate at a daily oral dose of 1 mg has been proven to have antivertebral fracture efficacy. In the present study, the efficacy and safety of oral minodronate at monthly doses of either 30 mg or 50 mg were compared with a daily dose of 1 mg. Methods A total of 692 patients with involutional osteoporosis were randomized to receive minodronate at either 30 or 50 mg monthly or a daily dose of 1 mg. The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at 12 months. Total hip BMD, bone turnover markers, serum calcium (Ca), and parathyroid hormone (PTH) levels were also evaluated. Results Minodronate at monthly doses of 30 or 50 mg were noninferior to the 1 mg daily dose in terms of change in LS-BMD. Changes in total hip BMD were also comparable. Although a transient decrease in serum Ca and increase in PTH levels were observed in all three groups at slightly different magnitudes and time courses, changes in bone turnover markers were comparable among the differentdosage groups with a similar time course. Safety profiles were also comparable. Conclusion Minodronate at monthly doses of 30 or 50 mg has similar efficacy to the daily 1 mg dose in terms of BMD and bone turnover markers with similar tolerability.
Keywords: Bone mineral density / Bone turnover marker / Minodronate / Monthly bisphosphonate / Osteoporosis / PTH
URI: http://hdl.handle.net/10069/29766
ISSN: 0937941X
DOI: 10.1007/s00198-011-1782-z
Rights: © The Author(s) 2011. This article is published with open access at Springerlink.com
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/29766

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