绝经后骨质疏松症女性患者接受地舒单抗治疗的真实世界管理：捷克共和国和斯洛伐克的前瞻性观察研究。
Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia.
机构信息
Institute of Rheumatology, Prague, Czech Republic.
Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.
出版信息
Adv Ther. 2018 Oct;35(10):1713-1728. doi: 10.1007/s12325-018-0779-9. Epub 2018 Sep 6.
INTRODUCTION
Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab.
METHODS
This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months.
RESULTS
A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, 'low BMD T score' and 'a history of osteoporotic fracture' were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7-91.7%; Slovakia, 67.1-92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab.
CONCLUSION
Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT01652690.
FUNDING
Amgen Inc.
简介
骨质疏松症的特征是骨矿物质密度（BMD）低，骨折风险增加。在随机对照试验中，地舒单抗已被证明可显著降低骨质疏松症女性的骨折风险。然而，对于接受地舒单抗治疗的女性的实际管理情况知之甚少。
方法
本研究在捷克共和国和斯洛伐克进行了一项多中心、前瞻性、观察性的真实世界研究，评估了接受地舒单抗治疗 24 个月的绝经后骨质疏松症女性的基线特征和临床管理情况。
结果
共纳入 600 名女性（每个国家 300 名）。在捷克共和国和斯洛伐克，入组时的平均年龄分别为 69.0 岁和 64.3 岁，分别有 67.7%和 30.0%的患者有既往骨质疏松性骨折，分别有 85.0%和 48.7%的患者既往接受过骨质疏松症药物治疗。两国均以“低 BMD T 评分”和“骨质疏松性骨折史”作为开具地舒单抗的主要原因。大多数患者接受了所有四次基线后地舒单抗注射（捷克共和国，82.0%；斯洛伐克，81.0%），两国均有超过 98%的患者在处方中心接受了所有注射。24 个月时，大多数患者的腰椎、全髋或股骨颈 BMD T 评分增加（捷克共和国，69.7-91.7%；斯洛伐克，67.1-92.9%）。药物不良反应与地舒单抗已知的安全性特征一致。
结论
在捷克共和国和斯洛伐克接受地舒单抗治疗的患者的基线特征反映了两国对地舒单抗的报销标准。本研究中高骨折风险患者的研究结果与越来越多的证据一致，证明了地舒单抗在真实世界临床实践中的有效性。
试验注册
ClinicalTrials.gov 标识符，NCT01652690。
资金
安进公司。
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