Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Pharmaco- and Device Epidemiology, Centre for Statistics in Medicine, Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
JAMA Netw Open. 2019 Apr 5;2(4):e192416. doi: 10.1001/jamanetworkopen.2019.2416.
Head-to-head randomized clinical trials showed greater efficacy of denosumab vs alendronate in improving bone mineral density. Although there is an association of changes in bone mineral density with reductions in fracture risk, the magnitude of the association is not well established.
To compare the risk of hip and any fracture in patients treated with denosumab and alendronate in routine practice settings.
DESIGN, SETTING, AND PARTICIPANTS: This Danish nationwide, population-based, historical cohort study of a population with universal access to health care used prospectively collected, individually linked data from Danish health registries with complete follow-up. Cohorts consisted of 92 355 individuals 50 years or older who were new users of denosumab (n = 4624) or alendronate (n = 87 731) from May 2010 to December 2017 after at least 1 year without an antiosteoporosis medication dispensing.
Initiation of denosumab or alendronate.
The primary outcome was hospitalization for hip fracture, and the secondary outcome was hospitalization for any fracture. Inverse probability of treatment weights and the intention-to-treat approach were used to calculate cumulative incidences and adjusted hazard ratios (aHRs) with 95% CIs.
Of the 92 355 included patients, 75 046 (81.3%) were women, and the mean (SD) age was 71 (10) years. The denosumab cohort had a lower proportion of men than the alendronate cohort (12.7% [589] vs 19.0% [16 700]), while age distributions were similar in the 2 cohorts. Within 3 years of follow-up, initiation of denosumab or alendronate was associated with cumulative incidences of 3.7% and 3.1%, respectively, for hip fracture and 9.0% and 9.0%, respectively, for any fracture. Overall, the aHRs for denosumab vs alendronate were 1.08 (95% CI, 0.92-1.28) for hip fracture and 0.92 (95% CI, 0.83-1.02) for any fracture. The aHR of denosumab vs alendronate for hip fracture was 1.07 (95% CI, 0.85-1.34) among patients with a history of any fracture and 1.05 (95% CI, 0.83-1.32) among patients without history of fracture. The aHR for any fracture for denosumab vs alendronate was 0.84 (95% CI, 0.71-0.98) among patients with a history of any fracture and 0.77 (95% CI, 0.64-0.93) among patients with no history of fracture.
Treatment with denosumab and alendronate was associated with similar risks of hip or any fracture over a 3-year period, regardless of fracture history.
头对头随机临床试验表明，地舒单抗比阿仑膦酸盐在改善骨密度方面更有效。尽管骨密度的变化与骨折风险的降低有关，但这种关联的程度尚未得到很好的确立。
比较在常规实践环境中使用地舒单抗和阿仑膦酸盐治疗的患者的髋部和任何骨折风险。
设计、设置和参与者：这项丹麦全国性、基于人群的、历史队列研究在全民医疗保健的背景下进行，使用了前瞻性收集的、个体链接的来自丹麦健康登记处的数据，随访完整。队列由 92355 名年龄在 50 岁及以上的个体组成，他们在至少 1 年没有使用抗骨质疏松药物后，于 2010 年 5 月至 2017 年 12 月首次使用地舒单抗（n=4624）或阿仑膦酸盐（n=87731）。
地舒单抗或阿仑膦酸盐的起始使用。
主要结局是髋部骨折住院，次要结局是任何骨折住院。使用逆概率治疗权重和意向治疗方法计算累积发生率和调整后的危险比（aHR）及其 95%置信区间（CI）。
在纳入的 92355 名患者中，75046 名（81.3%）为女性，平均（SD）年龄为 71（10）岁。地舒单抗组的男性比例低于阿仑膦酸盐组（12.7%[589] vs 19.0%[16700]），而两组的年龄分布相似。在 3 年的随访期内，地舒单抗或阿仑膦酸盐的起始治疗分别与髋部骨折的累积发生率为 3.7%和 3.1%，任何骨折的累积发生率为 9.0%和 9.0%相关。总体而言，地舒单抗与阿仑膦酸盐相比，髋部骨折的 aHR 为 1.08（95%CI，0.92-1.28），任何骨折的 aHR 为 0.92（95%CI，0.83-1.02）。对于有任何骨折史的患者，地舒单抗与阿仑膦酸盐相比，髋部骨折的 aHR 为 1.07（95%CI，0.85-1.34），对于无骨折史的患者，aHR 为 1.05（95%CI，0.83-1.32）。对于有任何骨折史的患者，地舒单抗与阿仑膦酸盐相比，任何骨折的 aHR 为 0.84（95%CI，0.71-0.98），对于无骨折史的患者，aHR 为 0.77（95%CI，0.64-0.93）。
在 3 年的时间内，使用地舒单抗和阿仑膦酸盐治疗与髋部或任何骨折的风险相似，无论是否有骨折史。
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