To assess the homogeneity of the treatment effects across pooled

To assess the homogeneity of the treatment effects across pooled centers, the percent change from baseline in selleck products lumbar spine BMD at Endpoint was analyzed using an ANOVA model with terms for treatment, baseline lumbar spine BMD, anti-coagulant use, pooled center, and treatment-by-pooled center interaction. Analysis of covariance (ANCOVA) was performed using two separate models to assess the effects

RAD001 of calcium and vitamin D supplement levels and the corresponding interactions; average daily dose was applied as the supplement level. The proportion of patients with at least one new vertebral body fracture of the thoracic or lumbar spine was compared to the IR daily group using the Fisher’s exact test for each DR group separately. The proportion of patients with adverse events by category was compared across all treatment groups using an overall Fisher’s exact test. Baseline characteristics of the treatment groups were compared using one-way ANOVA for continuous variables and Fisher’s exact test for categorical variables. 7-Cl-O-Nec1 Unless noted otherwise, all statistical analyses were two-sided, with a type I error rate of 0.05, and no adjustments were made for

multiplicity. Results Subjects From 1,859 women who were screened, 923 subjects were randomized, and 922 subjects received at least one dose of study drug (Fig. 1). Baseline characteristics were similar across treatment groups (Table 1). A similar percentage of subjects in each treatment group completed 12 months of the study (IR daily group, 83.7%; DR FB weekly group, 82.1%; DR BB weekly group, 83.8%). The most common reasons given for withdrawal were adverse event and voluntary withdrawal, which occurred at similar incidences across all three

treatment groups. Voluntary withdrawals were, by definition, Unoprostone unrelated to adverse events and usually were attributed by the subject to inconvenience or inability to travel to the clinic. A high percentage of intent-to-treat subjects in all groups (94.8% of subjects in the IR daily group, 96.1% of subjects in the DR FB weekly group, and 91.9% of subjects in the DR BB weekly group) took at least 80% of the study tablets. Fig. 1 Disposition of subjects Table 1 Summary of baseline characteristics   Risedronate 5 mg IR daily 35 mg DR FB weekly 35 mg DR BB weekly (N = 307) (N = 307) (N = 308) Age (years), mean (SD) 65.3 (7.4) 65.8 (7.4) 66.0 (7.5) Years since menopause, mean (SD) 17.5 (8.6) 18.2 (8.0) 18.8 (8.5) Years since last menses (n [%])  5 to 10 years 78 (25.4) 60 (19.5) 62 (20.1)  More than 10 years 229 (74.6) 247 (80.5) 246 (79.9) Race (n [%])  White 306 (99.7) 305 (99.3) 306 (99.4)  Asian (Oriental) 1 (0.3) 1 (0.3) 0 (0.0)  Multi-racial 0 (0.0) 1 (0.3) 2 (0.6) Prevalent vertebral fracture (n [%]) 70 (24.1)a 81 (28.2)a 87 (29.1)a Standardizedb lumbar spine bone BMD (mg/cm2), mean (SD) 762 (60) 763 (68) 763 (73) Lumbar spine BMD T-score, mean (SD) −3.12 (0.52) −3.11 (0.

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