Among the biochemical markers, serum TRACP-5b is a marker that has become available recently. The result of the subgroup analysis for serum TRACP-5b was in line with the results of other biochemical markers, showing higher mean percent changes from baseline in (L2–L4) BMD at the end of the study (M12, LOCF) in the subgroup of subjects with higher baseline values. Additionally, all biochemical markers showed a clinically significant RNA Synthesis inhibitor change from baseline at the end of the study (M12, LOCF), including the percent change for serum TRACP-5b of approximately − 40%, where
12.4% is the minimum significant change previously reported for serum TRACP-5b [25]. In order to further explore the relationship between BMD and the biochemical markers, Spearman correlation coefficients were calculated. Selleckchem PLX3397 The correlation coefficients between the primary endpoint and the percent change at the end of the study (M12, LOCF) for the biochemical markers,
serum BAP, urinary DPD/CRN, urinary NTX/CRN, urinary CTX/CRN, and serum TRACP-5b, were − 0.378, − 0.196, − 0.341, − 0.248, and − 0.378, respectively. Serum TRACP-5b had a correlation coefficient similar to that of other biochemical markers, demonstrating it to be as useful a marker as the other biochemical markers in monitoring risedronate treatment. The frequency of new vertebral fractures (including aggravation of prevalent vertebral
fractures) at the end of the study (M12, LOCF) was shown to be similar in the two treatment groups. The incidence of non-vertebral fractures was numerically smaller in the 75 mg once-monthly group than in the 2.5 mg once-daily group [2.1% (9/422) vs. 3.0% (13/428), respectively]. The vertebral antifracture efficacy of once-daily regimens has been verified in clinical trials. The clinical literature advocates BMD as a surrogate marker for vertebral antifracture efficacy [26]. In the current study, 75 mg once-monthly was non-inferior mafosfamide to 2.5 mg once-daily in mean percent change from baseline in BMD, suggesting that once-monthly risedronate could be expected to possess antifracture efficacy similar to that observed with the once-daily regimen. Similar to other bisphosphonates, risedronate is absorbed rapidly into bone tissue after administration but it is not readily degraded in vivo, resulting in an extremely long half-life in bone. Intermittent administration of risedronate is considered to have the same effect as daily administration where appropriate dose and dosing intervals have been established. In the current study, subjects in the 75 mg once-monthly group received a larger amount of drug per administration than did those in the 2.5 mg once-daily group, which results in the same total dose in a month.
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