Therefore, a part of vertebral fractures identified after 6 months of drug administration might have occurred before drug administration was started. Although the exact reason why a large number of vertebral fractures
occurred during the early period in both groups remains unclear, minodronate showed a marked anti-fracture efficacy from 6 to 24 months of treatment (Table 2). In contrast to the robust inhibitory effect on vertebral fractures, the present study did not show a significant effect of minodronate in reducing non-vertebral fractures. This is a major limitation of the present study. Because the study was aimed to examine the ability of minodronate to reduce the risk of vertebral fractures, the study did not have PXD101 mw enough power
in terms of NVP-HSP990 cost the number of study subjects and the length of study period to examine the effect of minodronate on non-vertebral fractures. Thus, although the study included patients with AZD9291 supplier established osteoporosis having at least one prevalent vertebral fracture, the number of non-vertebral fractures developed in long bones during the 24-month study period was too small to draw any conclusions. With regard to the safety profile of minodronate, no significant difference was observed between the minodronate and placebo groups in any AEs including drug-related or serious AEs. Although the most common AEs were gastrointestinal AEs, the incidence of gastrointestinal AEs, as well as those that caused discontinuation from the study, was very similar between the minodronate and placebo groups. These results suggest that minodronate does not cause any serious disturbance in osteoporotic patients, and daily administration of minodronate can be well-tolerated in patients
with osteoporosis. Minodronate exhibits very similar antiresorptive potency to zoledronic acid in pre-clinical studies [7], and intermittent oral administration of ibandronate Ureohydrolase [15] as well as yearly intravenous administration of zoledronic acid [16] demonstrated potent anti-fracture efficacy. Therefore, further studies are warranted to examine the effect of intermittent oral and intravenous minodronate on vertebral and non-vertebral fractures in osteoporotic patients. In conclusion, daily oral minodronate is safe, well-tolerated, and is effective in reducing vertebral fracture risk in postmenopausal women with established osteoporosis. Because the dose of minodronate in reducing fracture incidence was low, further studies are warranted to evaluate the efficacy of intermittent administration of higher doses of minodronate on osteporotic fractures. Acknowledgments We thank Mr. T. Minamide and Mr. T. Matsuoka, ONO Pharmaceutical Co., Ltd., for their scientific and technical support, Astellas Pharmaceutical, for providing supportive data, and the following investigators and clinical sites in Japan that participated in this study: T.
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