作者:Roux C;Reid DM;Devogelaer JP;Saag K;Lau CS;Reginster JY;Papanastasiou P;Bucci-Rechtweg C;Su G;Sambrook PN
本研究总结了输注唑来膦酸对糖皮质激素诱导的不同亚组骨质疏松症患者腰椎骨矿物密度的治疗作用。唑来膦酸预防和治疗糖皮质激素诱导的骨质疏松症时,对于增加腰椎(LS)骨矿物质密度(BMD)的疗效显著优于利塞膦酸。
前言:在接受糖皮质激素治疗的患者,单次输注唑来膦酸与每日口服利塞膦酸相比可显著增加骨密度。我们评估了接受糖皮质激素治疗后具有骨质疏松症风险患者使用唑来膦酸和利塞膦酸治疗12个月对LS BMD的治疗效果。
方法:患者随机接受单次静脉注射唑来膦酸5mg或口服利塞膦酸钠(5mg/d),根据糖皮质激素的疗程[治疗(> 3个月)和预防(</ = 3个月)亚群]进行分层,并根据年龄、性别、绝经期状态、试验期间强的松的剂量和疗程、基线血清25-羟基维生素D、LS BMD T值、肌酐清除率和同时服用的药物分成不同亚组。
结果:12个月时,唑来膦酸与利塞膦酸相比,显著增加</ = 74岁(P <0.05)治疗组患者和65-74岁预防亚组患者的LS BMD(P = 0.0008)。在12个月时,唑来膦酸与利塞膦酸钠相比显著增加两个亚组的LS BMD,且无论性别(均P <0.05)、累计泼尼松剂量(P均<0.01),绝经后状态(P均<0.05)。在绝经前妇女的两个亚群中,12个月时唑来膦酸较利塞膦酸钠显著增加总髋部BMD(P均<0.05),而非LS BMD。骨质疏松症预防(P = 0.0189)和骨质减少的治疗患者亚群(P = 0.0305)中,唑来膦酸与利塞膦酸钠治疗相比,12个月时LS BMD显著增加。
结论:本项事后分析表明,对于预防和治疗糖皮质激素诱导的骨质疏松症,唑来膦酸增加LS BMD的作用显著优于利塞膦酸钠。
This study summarizes the treatment effect of zoledronic acid infusion on lumbar spine bone mineral density in different subgroups with glucocorticoid-induced osteoporosis. Zoledronic acid is significantly more effective than risedronate in increasing lumbar spine (LS) bone mineral density (BMD) in both prevention and treatment of glucocorticoid-induced osteoporosis. INTRODUCTION: In patients on glucocorticoids, a single zoledronic acid infusion significantly increased BMD versus daily oral risedronate. We assessed treatment effect on LS BMD in different patient subgroups at month 12 that contributed to the risk of osteoporosis in addition to glucocorticoids. METHODS: Patients randomized to a single IV infusion of zoledronic acid 5 mg or risedronate (5 mg/day) and stratified based on glucocorticoids duration [treatment (>3 months) and prevention (</=3 months) subpopulations] were subgrouped by age; gender; menopausal status in women; dose and duration of prednisone during the trial; and baseline serum 25-OH vitamin D, LS BMD T-score, creatinine clearance, and concomitant medication use. RESULTS: At month 12, zoledronic acid significantly increased LS BMD versus risedronate in patients </=74 years (P < 0.05) in the treatment and 65-74 years (P = 0.0008) in the prevention subpopulation. At month 12, zoledronic acid significantly increased LS BMD versus risedronate in both subpopulations irrespective of gender (all P < 0.05), cumulative prednisone dose (all P < 0.01), and postmenopausal status (all P < 0.05). In premenopausal women, in both subpopulations, zoledronic acid significantly increased total hip BMD (all P < 0.05) versus risedronate at month 12 but not LS BMD. Osteoporotic patients in the prevention (P = 0.0189) and osteopenic patients in the treatment subpopulation (P = 0.0305) showed significant LS BMD increases with zoledronic acid versus risedronate at month 12. CONCLUSIONS: This post hoc analysis suggests that zoledronic acid is significantly more effective than risedronate in increasing LS BMD in prevention and treatment of glucocorticoid-induced osteoporosis across a wide range of patients.
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