Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan.
Osteoporos Int. 2012 Feb;23(2):695-703. doi: 10.1007/s00198-011-1556-7. Epub 2011 Mar 11.
A 36-month observational study compared the incidence of unaffected side hip fracture in Japanese female osteoporosis patients with a history of hip fracture between 173 patients receiving risedronate and 356 risedronate-untreated controls. New hip fractures were significantly less frequent in the risedronate group, suggesting a preventive effect in high-risk patients.
The purpose of this study was to investigate the preventive effect of risedronate on second hip fracture immediately following a first hip fracture in Japanese female osteoporosis patients with unilateral hip fracture.
We conducted a prospective matched cohort study in 184 patients treated with risedronate and 445 patients not receiving risedronate after discharge from hospital. Both groups were followed-up for 36 months, and the incidence of unaffected side hip fracture and the frequency of adverse events were assessed.
Efficacy could be investigated in 173 patients from the risedronate group and 356 patients from the control group. Hip fracture was detected in 5 and 32 patients, respectively. Kaplan-Meier estimates of the 36-month fracture incidence were 4.3% in the risedronate group and 13.1% in the control group (P = 0.010, log-rank test). The hazard ratios (95% confidence intervals) obtained by univariate and multivariate analysis were 0.310 (0.121-0.796) and 0.218 (0.074-0.639), respectively, indicating a significantly lower incidence of unaffected side hip fracture in the risedronate group. Adverse events occurred in 38 patients (48 events) from the risedronate group and 94 patients (108 events) from the control group, with serious adverse events in 21 patients (26 events) and 78 patients (88 events), respectively.
No significant differences were observed between the two groups. The incidence of unaffected side hip fracture was significantly lower in the risedronate group. Accordingly, risedronate may have a preventive effect on hip fracture in high-risk Japanese female osteoporosis patients for fracture with a history of unilateral hip fracture.
一项为期 36 个月的观察性研究比较了 173 例接受利塞膦酸钠治疗和 356 例未接受利塞膦酸钠治疗的患者中，有髋部骨折病史的日本女性骨质疏松症患者中未受影响侧髋部骨折的发生率。利塞膦酸钠组新发髋部骨折的频率明显较低，表明该药物对高危患者具有预防作用。
本研究旨在探讨利塞膦酸钠对单侧髋部骨折的日本女性骨质疏松症患者初次髋部骨折后再次发生第二侧髋部骨折的预防作用。
我们对 184 例接受利塞膦酸钠治疗和 445 例出院后未接受利塞膦酸钠治疗的患者进行了前瞻性匹配队列研究。两组均随访 36 个月，评估未受影响侧髋部骨折的发生率和不良事件的发生频率。
利塞膦酸钠组 173 例和对照组 356 例患者可进行疗效评估。分别在 5 例和 32 例患者中发现髋部骨折。利塞膦酸钠组和对照组患者 36 个月时的骨折发生率估计值分别为 4.3%和 13.1%（P=0.010，对数秩检验）。单变量和多变量分析得到的风险比（95%置信区间）分别为 0.310（0.121-0.796）和 0.218（0.074-0.639），表明利塞膦酸钠组未受影响侧髋部骨折的发生率显著降低。利塞膦酸钠组有 38 例（48 例事件）和对照组 94 例（108 例事件）发生不良事件，其中严重不良事件分别为 21 例（26 例事件）和 78 例（88 例事件）。
两组之间无显著差异。利塞膦酸钠组未受影响侧髋部骨折的发生率显著降低。因此，利塞膦酸钠可能对有单侧髋部骨折病史的高危日本女性骨质疏松症患者的髋部骨折具有预防作用。
