Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS).

Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS).
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DOI:
10.1007/s00198-010-1498-5
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发表时间:
2011-10
影响因子:
4
通讯作者:
Lems, W. F.
Lems, W. F.
中科院分区:
医学2区
文献类型:
--
作者:
Fahrleitner-Pammer, A.;Langdahl, B. L.;Marin, F.;Jakob, F.;Karras, D.;Barrett, A.;Ljunggren, O.;Walsh, J. B.;Rajzbaum, G.;Barker, C.;Lems, W. F.

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在这项对患有严重骨质疏松症的绝经后女性进行的观察性研究中,骨折的发生率在18个月的teriparbal治疗期间降低,在随后的18个月teriparbal治疗后期间,当大多数患者服用其他骨质疏松症药物时,没有进一步变化的证据。骨折复位伴随着背痛的减轻。描述在正常临床实践中,18个月teriparbal治疗期间和18个月teriparbal治疗后,患有严重骨质疏松症的绝经后妇女的骨折结局和背痛。欧洲Forsteo观察性研究(EFOS)是一项前瞻性、多国、观察性研究。收集了临床骨折和背痛事件的数据(100 mm视觉疼痛量表[VAS]和问卷)。骨折数据以6个月为间隔进行总结,并使用重复测量的逻辑回归进行分析。使用重复测量模型分析背痛VAS较基线的变化。在36个月的随访期间,1,576例患者中共有208例(13.2%)发生258处骨折:34%为临床椎体骨折,66%为非椎体骨折。经调整的骨折几率在特立帕替尼治疗期间降低,在特立帕替尼治疗后18个月期间没有进一步变化的证据,在此期间,63.3%的患者服用双膦酸盐。与前6个月相比,30至<36个月期间骨折的调整几率降低了74%(p < 0.001)。在特立帕肽治疗期间背痛减轻,并且这种减轻在特立帕肽停用后持续。36个月后,校正的平均背痛VAS从基线平均值57.8 mm降低了26.3 mm(p < 0.001)。在现实生活中的临床环境中,骨折的风险在特立帕肽治疗期间降低,在特立帕肽停药后没有进一步变化的证据。治疗期间观察到的背痛变化在特立帕肽停药后至少维持18个月。这些结果应在观察性研究设计的背景下进行解释。本文的在线版本(doi:10.1007/s 00198 -010-1498-5)包含补充材料,可供授权用户使用。
In this observational study in postmenopausal women with severe osteoporosis, the incidence of fractures was decreased during 18 months of teriparatide treatment with no evidence of further change in the subsequent 18-month post-teriparatide period when most patients took other osteoporosis medications. Fracture reduction was accompanied by reductions in back pain. To describe fracture outcomes and back pain in postmenopausal women with severe osteoporosis during 18 months of teriparatide treatment and 18 months post-teriparatide in normal clinical practice. The European Forsteo Observational Study (EFOS) was a prospective, multinational, observational study. Data on incident clinical fractures and back pain (100 mm Visual Analogue Scale [VAS] and questionnaire) were collected. Fracture data were summarised in 6-month intervals and analysed using logistic regression with repeated measures. Changes from baseline in back pain VAS were analysed using a repeated measures model. A total of 208 (13.2%) of 1,576 patients sustained 258 fractures during 36 months of follow-up: 34% were clinical vertebral fractures and 66% non-vertebral fractures. The adjusted odds of fracture were reduced during teriparatide treatment and there was no evidence of further change in the 18-month post-teriparatide period, during which 63.3% patients took bisphosphonates. A 74% decrease in the adjusted odds of fracture in the 30- to <36-month period compared with the first 6-month period was observed (p < 0.001). Back pain decreased during teriparatide treatment and this decrease was sustained after teriparatide discontinuation. Adjusted mean back pain VAS decreased by 26.3 mm after 36 months (p < 0.001) from baseline mean of 57.8 mm. In a real-life clinical setting, the risk of fracture decreased during teriparatide treatment, with no evidence of further change after teriparatide was discontinued. The changes in back pain seen during treatment were maintained for at least 18 months after teriparatide discontinuation. These results should be interpreted in the context of the design of an observational study. The online version of this article (doi:10.1007/s00198-010-1498-5) contains supplementary material, which is available to authorized users.
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