Significantly Reduced Burst Release by Sequestration of Protein Delivery Vehicle Within Unique Three-Phase Composite Scaffold for Bone Tissue Engineering and Regenerative Medicine

Abstract

risedronate for 7 years). Re-initiation of risedronate therapy in years 9-10 led to decreases in uNTX and increases in LS BMD. Median percent decreases in uNTX from year 9 baseline were observed at months 3, 6, 12, 24 and endpoint (end evaluation obtained through month 24). Median percent decreases from baseline of greatest magnitude occurred at month 12 for both placebo/risedronate (-40%) and risedronate (-27%) groups. In years 9-10, mean percent increases from pivotal study baseline were noted in LS BMD for both groups, with risedronate patients having a trend to greater increases compared with placebo/risedronate patients (16.9%, 95% confidence interval (CI): 7.6, 26.1 vs 4.5%, 95% CI: -5.5, 14.5 at endpoint). The AE profile was similar between the 2 groups and consistent to that observed in previous trials. Conclusions: Re-initiation of risedronate therapy in years 9-10 in patients who had previously received risedronate for 2 or 7 years, followed by 1 year of risedronate discontinuation, led to decreases in uNTX and increases in LS BMD, indicating that the bone was still responsive to risedronate therapy after long-term treatment. Conflict of interest: Funding was provided by the Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and sanofi-aventis); RE and RH have received grant funding from the Alliance and RE has acted as paid consultant; DW is a Procter & Gamble Pharmaceuticals employee.