Cedars-Sinai/UCLA and OMC Clinical Research Center, 8641 Wilshire Boulevard, Suite 301, Beverly Hills, CA 90211, USA.
Osteoporos Int. 2012 Apr;23(4):1361-9. doi: 10.1007/s00198-011-1720-0. Epub 2011 Jul 19.
In the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study, women with incident clinical fractures reported significant declines in health-related quality of life (HRQoL). The largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain.
In the FREEDOM trial, denosumab significantly reduced the risk of new vertebral, hip, and nonvertebral fractures. We evaluated the effect of denosumab on HRQoL and the association between incident clinical fractures and HRQoL.
The FREEDOM trial enrolled 7,868 women aged 60-90 years with a total hip and/or lumbar spine BMD T-score <-2.5 and not <-4.0 at either site. Women were randomized to receive denosumab 60 mg or placebo every 6 months, in addition to daily calcium and vitamin D. HRQoL was assessed with the Osteoporosis Assessment Questionnaire-Short Version (OPAQ-SV) at baseline and every 6 months for 36 months. The OPAQ-SV assesses physical function, emotional status, and back pain. Higher scores indicate better health status.
No statistically significant differences in mean change in HRQoL from baseline to end of study were found when comparing treatment groups. Compared with women without any incident fractures during the study, women with incident clinical fractures reported significant declines in physical function (-4.0 vs. -0.5) and emotional status (-5.0 vs. -0.8) at month 36 (P < 0.001 for both). Importantly, time-dependent covariate analyses demonstrated that the largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain.
These findings not only demonstrate that incident clinical fractures impact HRQoL but also contribute new information regarding the impact of these fracture events on HRQoL over time.
在每 6 个月评估地舒单抗治疗骨质疏松症骨折降低作用（FREEDOM）研究中，发生临床骨折的女性报告其健康相关生活质量（HRQoL）显著下降。在骨折后<3 个月时观察到最大降幅。发生临床骨折对身体功能的影响最大，发生临床椎体骨折对背痛的影响最大。
在 FREEDOM 试验中，地舒单抗显著降低了新发椎体、髋部和非椎体骨折的风险。我们评估了地舒单抗对 HRQoL 的影响以及临床骨折与 HRQoL 之间的关联。
FREEDOM 试验纳入了 7868 名年龄在 60-90 岁之间的女性，这些女性的全髋部和/或腰椎骨密度 T 评分<-2.5，且在两个部位均未达到 <-4.0。这些女性被随机分配接受地舒单抗 60 mg 或安慰剂，每 6 个月一次，同时每日补充钙和维生素 D。使用骨质疏松症评估问卷-短版（OPAQ-SV）在基线和 36 个月的每 6 个月评估 HRQoL。OPAQ-SV 评估身体功能、情绪状态和背痛。得分越高表明健康状况越好。
与治疗组相比，从基线到研究结束时，HRQoL 平均变化无统计学显著差异。与研究期间未发生任何临床骨折的女性相比，发生临床骨折的女性在 36 个月时报告身体功能（-4.0 与 -0.5）和情绪状态（-5.0 与 -0.8）显著下降（均 P<0.001）。重要的是，时间依赖协变量分析表明，在骨折后<3 个月时观察到最大降幅。发生临床骨折对身体功能的影响最大，发生临床椎体骨折对背痛的影响最大。
这些发现不仅表明临床骨折会影响 HRQoL，而且还提供了有关这些骨折事件随时间对 HRQoL 影响的新信息。
