The assessment of prevalent fractures was made if the ratio of anterior or middle vertebral body height to the posterior vertebral body height
was less than 0.8 [10]. Quantitative and semiquantitative techniques [11, 12] were used to identify incident vertebral fractures in order to determine efficacy. Lateral radiographs of the spine were performed at 12 months for the assessment PLX-4720 datasheet of incident fractures. A new vertebral fracture was diagnosed if the anterior, posterior, or middle vertebral height had decreased by at least 15% and by 4 mm in a vertebra that was normal at baseline, or diagnosed semiquantitatively by grade progression [10]. Morphological diagnosis of fractures was made by quantitative and semiquantitative assessment of the images using the sequence of films at the central reading facilities of the University of Occupational and Environmental Health, Fukuoka, Japan by T. Nakamura. Assessment of nonvertebral fractures All nonvertebral fractures were identified symptomatically as clinical fractures, and only nontraumatic fractures assessed by investigators were reported. Suspected clinical fractures at six nonvertebral sites (humerus, radius/ulna,
subclavia, pelvis, femur, and tibia/fibula) were adjudicated radiographically, and only radiographically confirmed fractures were listed. Assessment of adverse selleck compound events All subjects were questioned about treatment-emergent adverse events (AEs) at each visit, and all adverse events reported were analyzed regardless of the investigators’ assessments of causality. The Medical Dictionary for Regulatory Activities (Version 13.0J) was used to categorize reported adverse events. Statistical NF-��B inhibitor analysis The primary hypothesis of the study was that monthly minodronate (30, 50 mg) would be comparable to daily minodronate (1 mg) in terms of the mean percent change from baseline in LS-BMD after 12 months of treatment. The primary hypothesis was tested using an intention-to-treat (ITT) analysis. The ITT population comprised all randomized subjects. Erythromycin The primary analysis used a last observation carried forward
approach for missing values. A Dunnett’s test was used to determine the noninferiority of each of the monthly minodronate groups compared to the daily minodronate group. Noninferiority was to be declared if the lower bound of the two-sided 95% confidence interval (95% CI) of difference did not exceed the predefined noninferiority margin of −1.9%. The group mean and standard deviation (SD) or standard error (SE) were calculated for the baseline characteristics, the percent changes from baseline in LS-BMD, total hip BMD, and bone turnover markers and were used to assess the significance of changes between each of the monthly minodronate groups and the daily minodronate group. A Dunnett’s test was used to determine whether each of the monthly minodronate groups was significantly different from the daily minodronate group.
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