Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO)

Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO)
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DOI:
10.1007/s00198-007-0488-8
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发表时间:
2008-04-01
影响因子:
4
通讯作者:
Marin, F.
Marin, F.
中科院分区:
医学2区
文献类型:
--
作者:
Cooper, C.;Jakob, F.;Marin, F.

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在这项对骨质疏松症治疗临床结果不佳的女性进行的观察性研究中,基线时发生骨折的女性比没有骨折的女性更有可能发生意外骨折,并且健康相关生活质量更差。 简介 严重骨质疏松症观察性研究 (OSSO) 旨在评估骨质疏松症治疗临床结果不充分的女性的骨折发生率和健康相关生活质量 (HRQoL)。 方法 绝经后女性(N=1,885) 患有骨质疏松症,并且对骨质疏松药物治疗临床反应不足,定义为:a) 尽管治疗一年仍出现脆性骨折(指数骨折,N=988),或 b) 由于不良反应和/或不依从性而停止药物治疗 (N=897),在一年内使用 EQ-5D 和 QUALEFFO 问卷评估 HRQoL。 结果 166 (8.8%) 女性总共发生 209 起骨折(1,139 起骨折/10,000 名女性年)。发生过指数骨折的女性比没有发生过骨折的女性更容易发生骨折(风险比 1.91;95% CI:1.37-2.66;p < 0.001)。基线时的合并症或抗抑郁药物的使用也会增加发生骨折的风险。无论指数骨折状态如何,发生骨折的女性 EQ-5D 健康状态总值和 QUALEFFO 评分中位数均较差。最差的分数出现在自我护理、日常活动和疼痛/不适的 EQ-5D 子领域。 结论 对骨质疏松症治疗反应不足的女性骨折发生率很高,这对 HRQoL 产生不利影响。
In this observational study of women with an inadequate clinical outcome to osteoporosis therapy, those with a fracture at baseline were more likely to sustain an incident fracture and have a worse health-related quality of life than those without prior fracture.Introduction The Observational Study of Severe Osteoporosis (OSSO) was designed to assess the fracture incidence and health-related quality of life (HRQoL) in women with an inadequate clinical outcome to osteoporosis therapy.Methods Post-menopausal women (N=1,885) with established osteoporosis and an inadequate clinical response to osteoporosis drug therapy defined as: a) a fragility fracture despite therapy for one year (index fracture, N=988), or b) discontinued drug therapy due to adverse effects and/or non-compliance (N=897), were assessed during one year for HRQoL using the EQ-5D and the QUALEFFO questionnaires.Results One hundred and sixty-six (8.8%) women had a total of 209 incident fractures (1,139 fractures/10,000 women-years). Women with an index fracture were more likely to sustain an incident fracture than those without prior fractures (hazard ratio 1.91; 95% CI: 1.37-2.66; p < 0.001). Co-morbidities or antidepressant use at baseline also increased the risk of incident fracture. Median total EQ-5D Health State Values and QUALEFFO scores were worse in women with an incident fracture regardless of index fracture status. The worst scores were reported in the EQ-5D sub-domains of self-care, usual activities and pain/discomfort.Conclusions Women with an inadequate response to osteoporosis therapy had a high rate of incident fracture which had an adverse impact on HRQoL.