Ensrud Kristine E, Taylor Brent C, Peters Katherine W, Gourlay Margaret L, Donaldson Meghan G, Leslie William D, Blackwell Terri L, Fink Howard A, Orwoll Eric S, Schousboe John
Department of Medicine and Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA Center for Chronic Disease Outcomes Research, VA Health Care System, Minneapolis, MN, USA
Department of Medicine and Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA Center for Chronic Disease Outcomes Research, VA Health Care System, Minneapolis, MN, USA.
BMJ. 2014 Jul 3;349:g4120. doi: 10.1136/bmj.g4120.
To quantify incremental effects of applying different criteria to identify men who are candidates for drug treatment to prevent fracture and to examine the extent to which fracture probabilities vary across distinct categories of men defined by these criteria.
Cross sectional and longitudinal analysis of a prospective cohort study.
Multicenter Osteoporotic Fractures in Men (MrOS) study in the United States.
5880 untreated community dwelling men aged 65 years or over classified into four distinct groups: osteoporosis by World Health Organization criteria alone; osteoporosis by National Osteoporosis Foundation (NOF) but not WHO criteria; no osteoporosis but at high fracture risk (at or above NOF derived FRAX intervention thresholds recommended for US); and no osteoporosis and at low fracture risk (below NOF derived FRAX intervention thresholds recommended for US).
Proportion of men identified for drug treatment; predicted 10 year probabilities of hip and major osteoporotic fracture calculated using FRAX algorithm with femoral neck bone mineral density; observed 10 year probabilities for confirmed incident hip and major osteoporotic (hip, clinical vertebral, wrist, or humerus) fracture events calculated using cumulative incidence estimation, accounting for competing risk of mortality.
130 (2.2%) men were identified as having osteoporosis by using the WHO definition, and an additional 422 were identified by applying the NOF definition (total osteoporosis prevalence 9.4%). Application of NOF derived FRAX intervention thresholds led to 936 (15.9%) additional men without osteoporosis being identified as at high fracture risk, raising the total prevalence of men potentially eligible for drug treatment to 25.3%. Observed 10 year hip fracture probabilities were 20.6% for men with osteoporosis by WHO criteria alone, 6.8% for men with osteoporosis by NOF (but not WHO) criteria, 6.4% for men without osteoporosis but classified as at high fracture risk, and 1.5% for men without osteoporosis and classified as at low fracture risk. A similar pattern was noted in observed fracture probabilities for major osteoporotic fracture. Among men with osteoporosis by WHO criteria, observed fracture probabilities were greater than FRAX predicted probabilities (20.6% v 9.5% for hip fracture and 30.0% v 17.4% for major osteoporotic fracture).
Choice of definition of osteoporosis and use of NOF derived FRAX intervention thresholds have major effects on the proportion of older men identified as warranting drug treatment to prevent fracture. Among men identified with osteoporosis by WHO criteria, who comprised 2% of the study population, actual observed fracture probabilities during 10 years of follow-up were highest and exceeded FRAX predicted fracture probabilities. On the basis of findings from randomized trials in women, these men are most likely to benefit from treatment. Expanding indications for treatment beyond this small group has uncertain value owing to lower observed fracture probabilities and uncertain benefits of treatment among men not selected on the basis of WHO criteria.
量化应用不同标准识别药物治疗预防骨折男性候选者的增量效应，并研究骨折概率在由这些标准定义的不同男性类别中的变化程度。
前瞻性队列研究的横断面和纵向分析。
美国男性多中心骨质疏松性骨折（MrOS）研究。
5880名65岁及以上未接受治疗的社区居住男性，分为四个不同组：仅根据世界卫生组织标准诊断为骨质疏松症；根据美国国家骨质疏松基金会（NOF）标准诊断为骨质疏松症但不符合世界卫生组织标准；无骨质疏松症但骨折风险高（达到或高于美国NOF推荐的FRAX干预阈值）；无骨质疏松症且骨折风险低（低于美国NOF推荐的FRAX干预阈值）。
确定接受药物治疗的男性比例；使用FRAX算法结合股骨颈骨密度计算的10年髋部和主要骨质疏松性骨折预测概率；使用累积发病率估计法计算的确诊髋部和主要骨质疏松性（髋部、临床椎体、腕部或肱骨）骨折事件的观察到的10年概率，并考虑死亡的竞争风险。
采用世界卫生组织定义，130名（2.2%）男性被诊断为骨质疏松症，另外422名通过应用NOF定义被诊断为骨质疏松症（骨质疏松症总患病率为9.4%）。应用NOF衍生的FRAX干预阈值导致另外936名（15.9%）无骨质疏松症的男性被确定为骨折风险高，使可能符合药物治疗条件的男性总患病率升至25.3%。仅根据世界卫生组织标准诊断为骨质疏松症的男性观察到的10年髋部骨折概率为20.6%，根据NOF（但不符合世界卫生组织）标准诊断为骨质疏松症的男性为6.8%，无骨质疏松症但被分类为骨折风险高的男性为6.4%，无骨质疏松症且被分类为骨折风险低的男性为1.5%。主要骨质疏松性骨折的观察骨折概率也呈现类似模式。在根据世界卫生组织标准诊断为骨质疏松症的男性中，观察到的骨折概率高于FRAX预测概率（髋部骨折为20.6%对9.5%，主要骨质疏松性骨折为30.0%对17.4%）。
骨质疏松症定义的选择和NOF衍生的FRAX干预阈值的使用对确定需要药物治疗预防骨折的老年男性比例有重大影响。在占研究人群2%的根据世界卫生组织标准诊断为骨质疏松症的男性中，10年随访期间实际观察到的骨折概率最高，且超过FRAX预测的骨折概率。根据女性随机试验的结果，这些男性最有可能从治疗中获益。由于观察到的骨折概率较低以及在未根据世界卫生组织标准选择的男性中治疗益处不确定，将治疗指征扩大到这一小群体之外的价值尚不确定。
Zotero 插件