PDF(Pubmed)
Abstract：
BACKGROUND: We aimed to compare the efficacy after switching from either bisphosphonates (BPs) or non-BPs (NBPs) to combination therapies of denosumab (DMAb) or zoledronic acid (Zol) with eldecalcitol (ELD) in bone mineral density (BMD) and bone metabolism and investigate the prognostic and risk factors of side effects of this therapy.
METHODS: One-hundred forty-eight patients with postmenopausal osteoporosis were recruited; their therapy was switched from BPs or NBPs to Zol or DMAb plus ELD (BP-Zol: 43, NBP-Zol: 32, BP-DMAb: 35, and NBP-DMAb: 38). Longitudinal changes in bone metabolic markers (P1NP and TRACP-5b) and BMD were evaluated.
RESULTS: In the BP-Zol group, P1NP did not change after 6 months and increased by 38.9% after 12 months. TRACP-5b decreased 15.8% after 6 months, but came back to baseline values 12 months after administration. In the rest of the groups, the bone metabolic markers remained suppressed after 6 and 12 months. Compared with baseline, all groups showed increase in BMD after 6 and 12 months. Bone metabolic markers at baseline were correlated with %change in lumbar spine BMD from baseline to 12 months. P1NP and 25-hydroxy vitamin D levels at baseline were identified as potential predictors of development of acute-phase reactions.
CONCLUSIONS: The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis.
METHODS: One-hundred forty-eight patients with postmenopausal osteoporosis were recruited; their therapy was switched from BPs or NBPs to Zol or DMAb plus ELD (BP-Zol: 43, NBP-Zol: 32, BP-DMAb: 35, and NBP-DMAb: 38). Longitudinal changes in bone metabolic markers (P1NP and TRACP-5b) and BMD were evaluated.
RESULTS: In the BP-Zol group, P1NP did not change after 6 months and increased by 38.9% after 12 months. TRACP-5b decreased 15.8% after 6 months, but came back to baseline values 12 months after administration. In the rest of the groups, the bone metabolic markers remained suppressed after 6 and 12 months. Compared with baseline, all groups showed increase in BMD after 6 and 12 months. Bone metabolic markers at baseline were correlated with %change in lumbar spine BMD from baseline to 12 months. P1NP and 25-hydroxy vitamin D levels at baseline were identified as potential predictors of development of acute-phase reactions.
CONCLUSIONS: The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis.
摘要：
背景：我们旨在比较从双膦酸盐（BP）或非BP（NBP）转换到地诺塞马（DMAb）或唑来膦酸（Zol）与eldecalcitol（ELD）的联合治疗后的疗效骨密度（BMD）和骨代谢，并研究该治疗副作用的预后和危险因素。
方法：招募了148名绝经后骨质疏松症患者；他们的治疗从BP或NBPs转换为Zol或DMAb加ELD（BP-Zol：43，NBP-Zol：32，BP-DMAb：35和NBP-DMAb：38）。评估骨代谢标志物（P1NP和TRACP-5b）和BMD的纵向变化。
结果：在BP-Zol组中，P1NP在6个月后没有变化，在12个月后增加了38.9%。TRACP-5b在6个月后下降了15.8%，但在给药后12个月恢复到基线值。在其他团体中，骨代谢标志物在6个月和12个月后仍然受到抑制。与基线相比，6个月和12个月后，所有组的BMD均增加。基线时的骨代谢标志物与腰椎BMD从基线到12个月的变化百分比相关。基线时的P1NP和25-羟基维生素D水平被确定为急性期反应发展的潜在预测因子。
结论：Zol或DMAb和ELD的联合治疗可在日本绝经后骨质疏松症患者首次给药后12个月时增加BMD，无论BP预处理。基线时的骨代谢标志物可能是对绝经后骨质疏松症中这些联合疗法引起的治疗反应和副作用的有用预测因子。
方法：招募了148名绝经后骨质疏松症患者；他们的治疗从BP或NBPs转换为Zol或DMAb加ELD（BP-Zol：43，NBP-Zol：32，BP-DMAb：35和NBP-DMAb：38）。评估骨代谢标志物（P1NP和TRACP-5b）和BMD的纵向变化。
结果：在BP-Zol组中，P1NP在6个月后没有变化，在12个月后增加了38.9%。TRACP-5b在6个月后下降了15.8%，但在给药后12个月恢复到基线值。在其他团体中，骨代谢标志物在6个月和12个月后仍然受到抑制。与基线相比，6个月和12个月后，所有组的BMD均增加。基线时的骨代谢标志物与腰椎BMD从基线到12个月的变化百分比相关。基线时的P1NP和25-羟基维生素D水平被确定为急性期反应发展的潜在预测因子。
结论：Zol或DMAb和ELD的联合治疗可在日本绝经后骨质疏松症患者首次给药后12个月时增加BMD，无论BP预处理。基线时的骨代谢标志物可能是对绝经后骨质疏松症中这些联合疗法引起的治疗反应和副作用的有用预测因子。
