Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group.
Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group.
复制标题
阿仑膦酸钠对患有椎体骨折的绝经后妇女因背痛引起的活动受限日和卧床不起日的影响。
DOI：
--
复制
发表时间：
2000
影响因子：
--
通讯作者：
S. Cummings
中科院分区：
文献类型：
--
作者：
M. Nevitt;D. Thompson;D. Black;S. Rubin;K. E. Ensrud;A. Yates;S. Cummings
背景
新的椎骨骨折的妇女有背痛和功能限制的风险增加，因为背痛。阿仑膦酸钠治疗绝经后骨质疏松妇女新发椎骨骨折的风险降低50%。
目的
确定阿仑膦酸钠治疗对患有脊椎骨折的绝经后妇女背痛天数的影响。
设计
为期3年的安慰剂对照、随机、双盲研究。
设置
美国15所大学的研究诊所。
参与者
共有2027名绝经后妇女，年龄在55至81岁之间，股骨颈骨密度低，先前存在椎骨骨折。
干预
阿仑膦酸钠（5 mg/d，2年，10 mg/d，第3年）或安慰剂。
主要观察指标
3年随访期间背痛的发生率和严重程度、背痛天数以及因背痛卧床休息或活动受限的天数。
结果
无论治疗分配如何，在随访期间，临床上确认的新椎骨骨折的女性由于骨折后背痛而卧床和活动受限的风险增加。接受阿仑膦酸钠治疗的女性在随访期间因背痛（P = 0.04）而卧床休息的天数平均减少3.2天（P = 0.001），活动受限的天数（不包括卧床休息的天数）平均减少11.4天。与安慰剂组相比，阿仑膦酸钠组卧床休息1天或以上（相对风险，0.68; 95%可信区间，0.53-0.87）、卧床休息7天或以上（0.44; 0.30-0.64）和活动受限7天或以上（0.87; 0.76-0.99）的风险降低。基线和研究结束时，治疗组之间背痛天数或背部相关残疾增加的频率无统计学显著差异。
结论
在有脊椎骨折的绝经后妇女中，阿仑膦酸钠治疗3年可减少因背痛导致的卧床不起和活动受限的天数。
BACKGROUND
Women with new vertebral fractures have an increased risk of back pain and functional limitation because of back pain. Alendronate sodium treatment reduces the risk of new vertebral fracture by 50% in postmenopausal women with osteoporosis.
OBJECTIVE
To determine the effect of alendronate therapy on days affected by back pain in postmenopausal women with existing vertebral fractures.
DESIGN
Three-year, placebo-controlled, randomized, double-blind study.
SETTING
Fifteen university-based research clinics in the United States.
PARTICIPANTS
A total of 2027 postmenopausal women aged 55 to 81 years with low femoral neck bone density and a preexisting vertebral fracture.
INTERVENTION
Alendronate sodium (5 mg/d for 2 years and 10 mg/d for the third year) or placebo.
MAIN OUTCOME MEASURES
Occurrence and severity of back pain, number of days with back pain, and number of days of bed rest or limited activity because of back pain during 3 years of follow-up.
RESULTS
Irrespective of treatment assignment, women with new, clinically recognized vertebral fractures during follow-up had an increased risk of days of bed disability and days of limited activity because of back pain after the fracture. Women receiving alendronate reported an average of 3.2 fewer days of bed rest (P = .001) and 11.4 fewer days of limited activity (not including days of bed rest) because of back pain (P = .04) during follow-up than those receiving placebo. In the alendronate group, relative to the placebo group, there was a reduced risk of 1 or more bed-rest days (relative risk, 0.68; 95% confidence interval, 0.53-0.87), of 7 or more bed-rest days (0.44; 0.30-0.64), and of 7 or more limited-activity days (0.87; 0.76-0.99). There were no statistically significant differences between treatment groups in the frequency of days of back pain or increases in back-related disability between baseline and study end.
CONCLUSION
In postmenopausal women with preexisting vertebral fracture, alendronate therapy for 3 years reduced the number of days of bed disability and days of limited activity caused by back pain.
影响因子：
5
作者：
MELTON, LJ;KAN, SH;RIGGS, BL
通讯作者：
RIGGS, BL