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首页> 外文期刊>The Journal of rheumatology >The impact of incident vertebral and non-vertebral fragility fractures on health-related quality of life in established postmenopausal osteoporosis: results from the teriparatide randomized, placebo-controlled trial in postmenopausal women.
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The impact of incident vertebral and non-vertebral fragility fractures on health-related quality of life in established postmenopausal osteoporosis: results from the teriparatide randomized, placebo-controlled trial in postmenopausal women.

机译：在已确立的绝经后骨质疏松症中，椎骨和非椎骨脆性骨折对健康相关生活质量的影响：绝经后妇女特立帕肽随机，安慰剂对照试验的结果。

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OBJECTIVE: To report the combined impact of both vertebral and non-vertebral fractures on decreased health-related quality of life (HRQOL) in postmenopausal women (mean age 70.7) with osteoporosis who participated in a clinical trial to examine the anti-fracture efficacy of teriparatide [rhPTH(1-34)] injection. METHODS: Patients were randomly assigned to 1 of 3 study arms: placebo, 20 micro g or 40 micro g of teriparatide by daily self-injection. All patients received daily calcium (1000 mg) and vitamin D (400-1200 U) supplements. Patients were followed for a median of 21 months. Incident vertebral fractures were assessed by lateral spinal radiograph. Incident non-vertebral fractures were ascertained by patient self-report and verified by a review of radiological reports. HRQOL was assessed at baseline and annually until study termination using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument. RESULTS: Of the 365 women in the HRQOL sub-study, 53 had an incident vertebral or non-vertebral fracture during the study period. Compared to women without incident fractures, women who fractured reported significant declines in physical functioning, emotional status, and symptoms (all p < 0.05). Similarly, when analysis was limited to patients with significant loss in HRQOL, patients with incident fracture accounted for a greater proportion of those patients with decreased physical function, emotional status, and increased symptoms (all p < 0.05). CONCLUSION: Our results confirm and extend previous findings to show that a composite endpoint of incident vertebral and non-vertebral fractures in women with postmenopausal osteoporosis was associated with significant decreases in HRQOL.
机译：目的：报告椎骨和非椎骨骨折对绝经后骨质疏松妇女（平均年龄70.7）的健康相关生活质量（HRQOL）下降的综合影响，这些妇女参加了一项临床试验，研究了该药的抗骨折功效特立帕肽[rhPTH（1-34）]注射剂。方法：通过每日自我注射，将患者随机分配至3个研究组中的1个：安慰剂，20微克或40微克的特立帕肽。所有患者每日接受钙（1000毫克）和维生素D（400-1200 U）补充。随访患者中位时间为21个月。通过脊柱侧位X线片评估椎体骨折的发生率。通过患者的自我报告确定非椎骨骨折的发生，并通过回顾放射学报告进行核实。 HRQOL在基线和每年进行评估，直到使用骨质疏松评估问卷（OPAQ）（一种经过验证的针对疾病的仪器）终止研究为止。结果：在HRQOL子研究中的365名妇女中，有53名在研究期间发生了脊椎或非脊椎骨折。与未发生骨折的女性相比，骨折的女性报告其身体机能，情绪状态和症状明显下降（所有p <0.05）。同样，当分析仅限于HRQOL明显降低的患者时，发生骨折的患者在那些身体功能下降，情绪状态和症状增加的患者中所占比例更大（所有p <0.05）。结论：我们的结果证实并扩展了先前的研究结果，表明绝经后骨质疏松妇女的椎骨和非椎体骨折的复合终点与HRQOL显着降低有关。

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