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Open Access 01-06-2012 | Original Article

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

Authors: R. Okazaki, H. Hagino, M. Ito, T. Sone, T. Nakamura, H. Mizunuma, M. Fukunaga, M. Shiraki, Y. Nishizawa, Y. Ohashi, T. Matsumoto

Published in: Osteoporosis International | Issue 6/2012

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 different dosage 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.

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Title: Efficacy and safety of monthly oral minodronate in patients with involutional osteoporosis
Authors: R. Okazaki
H. Hagino
M. Ito
T. Sone
T. Nakamura
H. Mizunuma
M. Fukunaga
M. Shiraki
Y. Nishizawa
Y. Ohashi
T. Matsumoto
Publication date: 01-06-2012
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 6/2012
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-011-1782-z

ACC 2024 Congress

Springer Medicine

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

Abstract

Summary

Introduction

Methods

Results

Conclusion

ACC 2024 Congress

Springer Medicine

Abstract

Summary

Introduction

Methods

Results

Conclusion

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