Mellström Dan, Yang Xiaoqin, Li Zhiyi, Fan Chun-Po Steve, Waern Ewa, Modi Ankita, Sajjan Shiva, Salomonsson Stina
Centre for Bone and Arthritis Research, University of Gothenburg, Gothenburg, Sweden.
Merck & Co., Inc., Kenilworth, New Jersey.
Clin Ther. 2016 Jul;38(7):1686-1695.e3. doi: 10.1016/j.clinthera.2016.05.005. Epub 2016 Jun 7.
Fragility fractures are a clinical consequence of osteoporosis (OP). Evidence suggests however, current OP treatments may be inadequate in reducing fracture risk. The purpose of this study was to estimate the proportion and characteristics of Swedish patients who remain at high risk of fracture after 2 years of treatment, as evidenced by osteoporotic bone mineral density (BMD), a decrease in BMD, or the occurrence of new fractures.
This was a retrospective, descriptive analysis of a subset of participants obtained from a Swedish osteoporosis patient registry from 1991 to 2009. Patients were required to be osteoporotic, to be treatment naive at baseline, to have returned for at least 1 follow-up visit, and to have reported osteoporosis treatment use for ≥2 years after the baseline visit with a BMD T score. Two overlapping cohorts remaining at high risk of fracture were defined using the BMD T score measured after 2 years of treatment from baseline. The osteoporosis cohort comprised patients who remained osteoporotic, whereas the BMD decrease cohort included patients whose total hip or lumbar spine T score decreased by ≥3%.
A total of 3292 osteoporotic patients were identified in the registry, of whom 392 met the study inclusion criteria. The mean (SD) patient age was 68.3 (8.5) years, with most patients being female (92.3%). Among all patients, 297 (75.8%) remained osteoporotic after at least 2 years of treatment, 90 (23.0%) experienced a BMD decrease of ≥3%, and 23 (5.9%) reported an incident fracture between the baseline and first follow-up visit. More than three-quarters (76.8%) of all patients reported taking bisphosphonates, whereas only 72.4% and 47.8% reported this in the osteoporosis and BMD decrease cohorts, respectively. Raloxifene was the only nonbisphosphonate used, with 24.2% of all patients reportedly taking it.
This study highlighted that despite 2 years of osteoporosis treatment, a high percentage of patients remain at high risk of fracture. There is a need for improved treatment strategies that reduce fracture risk and improve patient outcomes in the real-world setting.
脆性骨折是骨质疏松症(OP)的临床后果。然而,有证据表明,目前的OP治疗在降低骨折风险方面可能并不充分。本研究的目的是评估经过2年治疗后仍处于高骨折风险的瑞典患者的比例和特征,这可通过骨质疏松性骨密度(BMD)、BMD降低或新发骨折的发生来证明。
这是一项对1991年至2009年从瑞典骨质疏松症患者登记处获取的部分参与者进行的回顾性描述性分析。患者必须患有骨质疏松症,基线时未接受过治疗,至少返回进行过1次随访,并且在基线访视后报告使用骨质疏松症治疗≥2年并伴有BMD T评分。使用从基线开始治疗2年后测量的BMD T评分定义了两个仍处于高骨折风险的重叠队列。骨质疏松症队列包括仍患有骨质疏松症的患者,而BMD降低队列包括全髋或腰椎T评分降低≥3%的患者。
登记处共识别出3292例骨质疏松症患者,其中392例符合研究纳入标准。患者的平均(标准差)年龄为68.3(8.5)岁,大多数患者为女性(92.3%)。在所有患者中,297例(75.8%)在至少2年的治疗后仍患有骨质疏松症,90例(23.0%)的BMD降低≥3%,23例(5.9%)在基线和首次随访之间报告发生了新发骨折。超过四分之三(76.8%)的所有患者报告服用双膦酸盐,而在骨质疏松症队列和BMD降低队列中分别只有72.4%和47.8%的患者报告服用。雷洛昔芬是唯一使用的非双膦酸盐药物,据报道所有患者中有24.2%服用该药。
本研究强调,尽管进行了2年骨质疏松症治疗,但仍有很大比例的患者处于高骨折风险。需要改进治疗策略,以在现实环境中降低骨折风险并改善患者预后。