No clinically important differences were seen across groups for any laboratory parameter measured, including measures of hepatic and renal function. Other
laboratory learn more safety parameters, including fecal occult blood tests, coagulation parameters, and electrocardiograms, revealed no adverse safety signals. Discussion Risedronate, as an IR tablet, has proven vertebral and nonvertebral antifracture efficacy. Due to poor bioavailability in the presence of food with all bisphosphonates, it is important that these medications be taken before the first food or drink of the day for optimal efficacy. With risedronate, patients must wait at least 30 min after CAL-101 in vitro dosing before eating or drinking anything other than water.
This study has shown that the novel risedronate 35 mg DR tablet, when taken once weekly either before or after breakfast, produces clinical effects similar to those seen with the risedronate 5 mg IR tablet taken daily as prescribed. Specifically, the mean percent changes in lumbar spine BMD at 52 weeks in the DR weekly groups were non-inferior to the mean percent change in the IR daily group. Changes in secondary efficacy parameters, including BMD at the hip, bone SBI-0206965 turnover markers and new morphometric vertebral fractures were generally similar in both DR weekly groups compared to the IR daily group. Statistically significant increases in femoral neck BMD, and decreases in bone turnover markers, were seen at some time points in the DR weekly groups compared to the IR daily group. The reason for the somewhat increased responses to the DR regimen
is unclear but is probably not explained by the difference in daily versus weekly dosing since the BMD and marker responses to daily and weekly risedronate IR did not differ . Even a modestly better bioavailability of the DR formulation compared to IR during the year of therapy could account for the difference. Alternatively, perhaps compliance with dosing Protirelin instructions was better with the weekly DR regimen compared to the daily IR regimen, even in the context of clinical trial where compliance with therapy is generally better than in daily clinical practice. The risedronate DR weekly regimen was generally well tolerated by postmenopausal women, with a safety profile similar to that seen with the risedronate daily regimen. Although upper abdominal pain and diarrhea were more frequent in the DR weekly groups, few subjects withdrew due to the events. Most events were mild or moderate in severity, suggesting these symptoms with the 35 mg DR weekly regimen will have a minimal impact on adherence to treatment in clinical use. The vertebral and nonvertebral antifracture efficacy of risedronate has been established in multiple large studies that had fracture as the primary Endpoint [12, 15, 16].