Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Jun;23(6):1737-45.
doi: 10.1007/s00198-011-1782-z. Epub 2011 Sep 20.

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

R Okazaki  1 , H Hagino, M Ito, T Sone, T Nakamura, H Mizunuma, M Fukunaga, M Shiraki, Y Nishizawa, Y Ohashi, T Matsumoto
Affiliations
Randomized Controlled Trial

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

R Okazaki et al. Osteoporos Int. 2012 Jun.

Abstract

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Enrollment and outcomes. A total of 1,093 patients were screened, of which 692 were randomized to take minodronate at 30 mg monthly (229 subjects), 50 mg monthly (229 subjects), or 1 mg daily (234 subjects)
Fig. 2
Fig. 2
Changes in lumbar spine and total hip bone mineral density. Data are means ± SE
Fig. 3
Fig. 3
Changes in bone turnover markers. Data are means ± SE
Fig. 4
Fig. 4
Changes in serum calcium and parathyroid hormone levels. Data are means ± SE. a Significantly different from baseline, p < 0.05; b significantly different from 1 mg daily group, p < 0.05
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009;44:1078–1084. doi: 10.1016/j.bone.2009.02.016. - DOI - PubMed
    1. Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009;20:1429–1437. doi: 10.1007/s00198-008-0816-7. - DOI - PMC - PubMed
    1. Rizzoli R, Greenspan SL, Bone G, 3rd, Schnitzer TJ, Watts NB, Adami S, Foldes AJ, Roux C, Levine MA, Uebelhart B, Santora AC, 2nd, Kaur A, Peverly CA, Orloff JJ. Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. J Bone Miner Res. 2002;17:1988–1996. doi: 10.1359/jbmr.2002.17.11.1988. - DOI - PubMed
    1. Brown JP, Kendler DL, McClung MR, Emkey RD, Adachi JD, Bolognese MA, Li Z, Balske A, Lindsay R. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 2002;71:103–111. doi: 10.1007/s00223-002-2011-8. - DOI - PubMed
    1. Uchida S, Taniguchi T, Shimizu T, Kakikawa T, Okuyama K, Okaniwa M, Arizono H, Nagata K, Santora AC, Shiraki M, Fukunaga M, Tomomitsu T, Ohashi Y, Nakamura T. Therapeutic effects of alendronate 35 mg once weekly and 5 mg once daily in Japanese patients with osteoporosis: a double-blind, randomized study. J Bone Miner Metab. 2005;23:382–388. doi: 10.1007/s00774-005-0616-5. - DOI - PubMed

Publication types

MeSH terms