Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.
Centre for Metabolic Bone Diseases, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.
Osteoporos Int. 2021 Oct;32(10):1951-1960. doi: 10.1007/s00198-021-05942-2. Epub 2021 Apr 4.
The National Osteoporosis Guideline Group (NOGG) has developed intervention thresholds based on FRAX® to characterise patients at high and very high risk of fracture.
Guidelines for the assessment of fracture risk have begun to categorise patients eligible for treatment into high and very high risk of fracture to inform choice of therapeutic approach. The aim of the present study was to develop intervention thresholds based on the hybrid assessment model of NOGG.
We examined the impact of intervention thresholds in a simulated cross-sectional cohort of women age 50 years or more from the UK with the distribution of baseline characteristics based on that in the FRAX cohorts. The prevalence of very high risk using the hybrid model was compared with age-dependent thresholds used by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (IOF/ESCEO). The appropriateness of thresholds was tested based on the populations treated with anabolic agents.
With an upper intervention threshold using the IOF/ESCEO criteria, 56% of women age 50 years or more would be characterised at very high risk. This compares with 36% using the IOF/ESCEO criteria and an age-specific intervention threshold over all ages. With an upper intervention threshold of 1.6 times the pre-existing intervention threshold, 10% of women age 50 years or more would be characterised at very high risk. The data from phase 3 studies indicate that most trial participants exposed to romosozumab or teriparatide would fall into the very high-risk category.
Proposals for FRAX-based criteria for very high risk for the NOGG hybrid model categorise a small proportion of women age 50 years or more (10%) in this highest risk stratum. The level of risk identified was comparable to that of women enrolled in trials of anabolic agents.
国家骨质疏松症指南小组(NOGG)已基于 FRAX®制定了干预阈值,以确定骨折高危和极高风险患者。
评估骨折风险的指南已开始将符合治疗条件的患者分为骨折高危和极高危患者,以确定治疗方法。本研究旨在基于 NOGG 的混合评估模型制定干预阈值。
我们使用英国年龄在 50 岁及以上女性的模拟横断面队列检查了干预阈值的影响,该队列的基线特征分布基于 FRAX 队列。使用混合模型计算的极高危患病率与国际骨质疏松基金会和欧洲骨质疏松症和骨关节炎临床和经济学会(IOF/ESCEO)的年龄依赖性阈值进行了比较。基于使用合成代谢药物治疗的人群对阈值的适宜性进行了测试。
使用 IOF/ESCEO 标准的较高干预阈值,56%的年龄在 50 岁及以上的女性将被归类为极高危。与使用 IOF/ESCEO 标准和所有年龄段的特定年龄干预阈值相比,这一比例为 36%。使用高于现有干预阈值 1.6 倍的干预阈值,年龄在 50 岁及以上的 10%女性将被归类为极高危。3 期研究的数据表明,大多数接受 romosozumab 或特立帕肽治疗的试验参与者将属于极高危类别。
NOGG 混合模型基于 FRAX 的极高危标准的建议将一小部分年龄在 50 岁及以上的女性(10%)归入风险最高的人群。确定的风险水平与接受合成代谢药物治疗的试验参与者的风险水平相当。