BMD Response to Delayed-Release Risedronate 35 Mg Once-A-Week Formulation Taken With or Without Breakfast

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or 1.8 and 3.5 (total hip or femoral neck) were randomized to receive placebo, alendronate (ALN), or 1 of 7 different doses of DMAb. After 2 years on study, subjects were reallocated to maintain, discontinue, or discontinue and reinitiate DMAb; discontinue ALN; or maintain placebo for 2 more years (Miller et al. Bone 2008). In a 4-year extension phase of this study, all subjects received open-label DMAb 60 mg subcutaneously every 6 months (Q6M). We report interim 2-year safety and efficacy analyses from the extension study, representing up to 6 years of exposure to DMAb. For the 124 subjects who received 6 years of continuous DMAb treatment, BMD continued to increase over the entire treatment period: 13.3% at the lumbar spine, 6.1% at the total hip, and 1.9% at the 1/3 radius compared with their parent study baseline. For the 23 subjects in the previous placebo cohort, 2 years of DMAb treatment resulted in gains in BMD at all sites comparable to those observed during the first 2 years of DMAb 60 mg Q6M in the parent study. Reductions in predose serum CTX and BSAP were sustained over the course of continuous DMAb treatment: the median reduction at year 6 was 55% for CTX and 42% for BSAP. Reductions in CTX and BSAP also were observed when the placebo group transitioned to DMAb treatment. Adverse events that occurred during the extension study were balanced and were similar to those observed during the parent study. Continuous treatment with DMAb resulted in sustained reduction in BTM and further gains in BMD over a period of up to 6 years in postmenopausal women with low bone mass. The overall safety profile in this ongoing study extension did not change over time.