Fig. 2 Mean percent change Oligomycin A molecular weight (±SEM) from baseline in bone mineral density in women receiving risedronate 5-mg daily (dashed line with triangles) or 150-mg once a month (solid line with circles). Endpoint refers to the value calculated using the last observation carried forward at month 24. There were no statistically significant differences between treatment groups at any time point at any of these sites. OAM once a month There was no difference between treatment
groups in the occurrence of new incident vertebral fracture as determined by morphometric measurement during the study; 14 subjects (2.5 %) in the 5-mg daily group and 15 subjects (2.6 %) in the 150-mg once-a-month group experienced such a fracture. Significant www.selleckchem.com/products/ABT-263.html decreases from baseline in NTX/Cr, CTX, and BALP were observed at 3, 6, 12, and 24 months in
both treatment groups (Fig. 3). In general, changes from baseline in these biochemical markers were similar in both treatment groups. The small difference in CTX between groups was statistically significant at months 3, 6, and 12 but not at month 24. There was no statistically significant difference between treatment groups at 3-Methyladenine order endpoint (the last-observation-carried forward values at month 24) for any of the biochemical markers of bone turnover. Fig. 3 Mean percent change (±SEM) from baseline in biochemical markers of bone turnover in women receiving risedronate 5-mg daily (dashed line with
triangles) or Cell press 150-mg once a month (solid line with circles). Endpoint refers to the value calculated using the last observation carried forward at month 24. CTX C-terminal crosslinking telopeptide of type I collagen, NTX N-terminal crosslinking telopeptide of type I collagen, OAM once a month. *p < 0.05 indicates a statistically significant difference between treatment groups (unadjusted for multiple comparisons) Safety assessments Overall, the frequency of adverse events was similar in both treatment groups (Table 1). Among the most common adverse events, only diarrhea and influenza were more frequent in the monthly group compared with the daily group after 24 months. The difference between groups in these adverse events was primarily driven by events reported during the first few months of the study. Most events of diarrhea were mild or moderate in severity. One subject (0.2 %) in the 5-mg daily group and six subjects (0.9 %) in the 150-mg once-a-month group withdrew from the study as a result of diarrhea. All events of influenza were mild or moderate in severity, most occurred more than 90 days after the start of treatment, and none of the subjects withdrew because of influenza. More patients in the 150-mg once-a-month group reported serious adverse events than in the 5-mg daily group (Table 1).