The month 24 non-inferiority “delta” was selected using the same

The month 24 non-inferiority “delta” was selected using the same rationale used BAY 73-4506 to select the

month 12 non-inferiority margin. In previous studies contrasting risedronate 5-mg daily and placebo for the treatment of postmenopausal osteoporosis, the mean percent change difference between the treatment groups in lumbar spine BMD from baseline to month 24 ranged from 4.1 to 5.4 %. Thus, using a “delta” of 2.0 % would maintain approximately 50 % of the effect size of the risedronate 5-mg daily dose relative to placebo at month 24. The treatment group differences at month 24 in percent changes in proximal femur BMD and bone turnover markers were analyzed using an ANOVA model; two-sided 95 % CIs for the treatment differences were constructed using the ITT population. The incidence of new vertebral fractures over 24 months was analyzed using Fisher’s exact test. Adverse events were summarized as frequency distribution tables and reported by treatment group. Results

Subjects From the total of 2,221 women who were screened, 1,294 subjects were randomized, and 1,292 subjects received at least one dose of study drug (Fig. 1). Overall, baseline characteristics were similar in both treatment groups. Demographics of the subjects in each treatment group have been reported previously [6]. A similar percentage of subjects in each treatment group completed 24 months of the study (5-mg daily group,

77.6 %; GSK1210151A 150-mg once-a-month group, 78.9 %). The most common reasons given for withdrawal {Selleck Anti-diabetic Compound Library|Selleck Antidiabetic Compound Library|Selleck Anti-diabetic Compound Library|Selleck Antidiabetic Compound Library|Selleckchem Anti-diabetic Compound Library|Selleckchem Antidiabetic Compound Library|Selleckchem Anti-diabetic Compound Library|Selleckchem Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|Anti-diabetic Compound Library|Antidiabetic Compound Library|buy Anti-diabetic Compound Library|Anti-diabetic Compound Library ic50|Anti-diabetic Compound Library price|Anti-diabetic Compound Library cost|Anti-diabetic Compound Library solubility dmso|Anti-diabetic Compound Library purchase|Anti-diabetic Compound Library manufacturer|Anti-diabetic Compound Library research buy|Anti-diabetic Compound Library order|Anti-diabetic Compound Library mouse|Anti-diabetic Compound Library chemical structure|Anti-diabetic Compound Library mw|Anti-diabetic Compound Library molecular weight|Anti-diabetic Compound Library datasheet|Anti-diabetic Compound Library supplier|Anti-diabetic Compound Library in vitro|Anti-diabetic Compound Library cell line|Anti-diabetic Compound Library concentration|Anti-diabetic Compound Library nmr|Anti-diabetic Compound Library in vivo|Anti-diabetic Compound Library clinical trial|Anti-diabetic Compound Library cell assay|Anti-diabetic Compound Library screening|Anti-diabetic Compound Library high throughput|buy Antidiabetic Compound Library|Antidiabetic Compound Library ic50|Antidiabetic Compound Library price|Antidiabetic Compound Library cost|Antidiabetic Compound Library solubility dmso|Antidiabetic Compound Library purchase|Antidiabetic Compound Library manufacturer|Antidiabetic Compound Library research buy|Antidiabetic Compound Library order|Antidiabetic Compound Library chemical structure|Antidiabetic Compound Library datasheet|Antidiabetic Compound Library supplier|Antidiabetic Compound Library in vitro|Antidiabetic Compound Library cell line|Antidiabetic Compound Library concentration|Antidiabetic Compound Library clinical trial|Antidiabetic Compound Library cell assay|Antidiabetic Compound Library screening|Antidiabetic Compound Library high throughput|Anti-diabetic Compound high throughput screening| during year 2 were adverse event and voluntary withdrawal, which occurred at similar incidences in both treatment groups. A high percentage of subjects in both groups (95.5 % of subjects in the 5-mg daily group and 95.7 % of subjects in the 150-mg once-a-month group) took at least 80 % of the study tablets. Fig. 1 Diflunisal Disposition of subjects. BMD bone mineral density Efficacy assessments The within-group mean percent changes from baseline in lumbar spine BMD were statistically significant in both treatment groups at each time point (Fig. 2). The mean percent changes at 24 months (95 % CI) were 3.9 % (3.43 to 4.42 %) for the 5-mg daily group and 4.2 % (3.68 to 4.65 %) for the 150-mg once-a-month group. The difference from the 5-mg daily group (daily minus once a month) in mean percent change from baseline in lumbar spine BMD at month 24 was –0.24 % (95 % upper confidence bound, 0.25 %). This upper boundary was well below the 2.0 % needed to establish non-inferiority; thus, the 150-mg once-a-month regimen was determined to be non-inferior to the 5-mg daily regimen at 24 months. Significant increases from baseline in BMD were observed at 6, 12, and 24 months in both treatment groups (Fig. 2).

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