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在社区经验中直接评估非椎体骨折(DANCE)观察性研究中接受特立帕肽治疗的既往有椎体或髋部骨折的患者。

Patients with prior vertebral or hip fractures treated with teriparatide in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study.

作者信息

Beall D P, Feldman R G, Gordon M L, Gruber B L, Lane J M, Valenzuela G, Yim D, Alam J, Krege J H, Krohn K

机构信息

Clinical Radiology of Oklahoma, 1800 S. Renaissance Blvd, Edmond, OK, 73013, USA.

Senior Clinical Trials, Inc., 23961 Calle de la Magdalena Suite 429, Laguna Hills, CA, 92653, USA.

出版信息

Osteoporos Int. 2016 Mar;27(3):1191-1198. doi: 10.1007/s00198-015-3353-1. Epub 2015 Nov 10.

Abstract

SUMMARY

In patients in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study with and without a prior vertebral or hip fracture, the incidence of nonvertebral fractures was lower with >6 months of teriparatide treatment than during the first 6 months.

INTRODUCTION

Clinical evidence on the effect of teriparatide in patients with prior fracture is limited. In the DANCE observational study, the incidence of nonvertebral fragility fractures (NVFX) decreased significantly in patients receiving teriparatide for >6 months (6-24 months) versus >0 to ≤6 months (reference period).

METHODS

We performed a post hoc analysis to assess the effect of teriparatide 20 μg/day in patients who entered DANCE with prior vertebral or hip fractures. The incidence of patients experiencing a NVFX for four 6-month intervals during and after treatment was compared with the reference period.

RESULTS

Overall, 4085 patients received ≥1 dose of teriparatide. Of 3720 with sufficient data for efficacy analysis, 692 had prior vertebral fracture, including 179 with previous kyphoplasty/vertebroplasty; 290 had prior hip fracture. These patients were older, and those with prior vertebral fractures had more comorbid conditions at baseline than those without prior vertebral fractures. The incidence of patients experiencing NVFX declined over time in all patient groups. The fracture incidence rate declined 49 and 46%, respectively, in patients with and without prior vertebral fracture and was 63 and 46% lower in patients with previous kyphoplasty/vertebroplasty and without prior vertebral fracture. NVFX declined 43 and 48% in patients with and without prior hip fracture. The reduced incidence over time was consistent in the subgroups (all interaction p values >0.05). Patients with prior fracture were more likely to experience serious adverse events.

CONCLUSION

The incidence of NVFX decreased over time in patients receiving teriparatide in DANCE regardless of prior fracture status.

摘要

摘要

在社区非椎体骨折直接评估(DANCE)观察性研究中,无论患者之前是否有椎体或髋部骨折,接受特立帕肽治疗超过6个月时非椎体骨折的发生率低于前6个月。

引言

关于特立帕肽对既往有骨折患者疗效的临床证据有限。在DANCE观察性研究中,接受特立帕肽治疗超过6个月(6 - 24个月)的患者与接受治疗0至≤6个月(参照期)的患者相比,非椎体脆性骨折(NVFX)的发生率显著降低。

方法

我们进行了一项事后分析,以评估每天20μg特立帕肽对入组DANCE研究时已有椎体或髋部骨折患者的疗效。将治疗期间及之后四个6个月间隔期内发生NVFX的患者发生率与参照期进行比较。

结果

总体而言,4085例患者接受了≥1剂特立帕肽。在3720例有足够数据进行疗效分析的患者中,692例有既往椎体骨折,其中179例曾接受过椎体后凸成形术/椎体成形术;290例有既往髋部骨折。这些患者年龄较大,与无既往椎体骨折的患者相比,有既往椎体骨折的患者在基线时合并症更多。所有患者组中发生NVFX的患者发生率均随时间下降。有和无既往椎体骨折的患者骨折发生率分别下降了49%和46%,曾接受椎体后凸成形术/椎体成形术且无既往椎体骨折的患者骨折发生率比无既往椎体骨折的患者低63%和46%。有和无既往髋部骨折的患者NVFX分别下降了43%和48%。各亚组中随时间发生率降低的情况是一致的(所有交互作用p值>0.05)。既往有骨折的患者更有可能发生严重不良事件。

结论

在DANCE研究中,无论既往骨折状态如何,接受特立帕肽治疗的患者NVFX发生率均随时间下降。

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