Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.
Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Arch Osteoporos. 2020 Feb 24;15(1):26. doi: 10.1007/s11657-020-00715-6.
Bone formation markers bone-specific alkaline phosphatase and osteocalcin are used in many clinical situations. Therefore, we calculated reference intervals for the two markers and investigated how they are influenced by several factors including sex and age. Furthermore, we established clinically relevant reference intervals for the two markers.
The bone turnover markers (BTMs), bone-specific alkaline phosphatase (bone ALP), and osteocalcin (OC), are frequently measured formation markers. The purpose of this study was to establish reference intervals (RIs) for the two BTMs in a general adult Danish population.
Bone ALP and OC were measured on the iSYS (IDS Plc) automatic analyzer in samples from the Danish Health2006 5-year follow-up study on serum from 2308 participants (54% women, age range 24-76). Participants with self-reported diagnosis of osteoporosis or receiving hormonal replacement were excluded from analyses while participants on hormonal contraceptives were included.
The geometric mean and 95%RI for bone ALP were 13.9 μg/L (7.6-25.6) for men and 13.8 μg/L (7.0-27.4) for women, while for OC 16.0 μg/L (7.5-34.4) for men and 18.6 μg/L (8.1-42.9) for women. Levels of bone ALP increased with increasing age (β 1.004, p < 0.001), while female sex had no effect. OC levels decreased with increasing age (β 0.998, p = 0.009) and increased with female sex (β 1.104, p < 0.001). Based on our findings, we propose for bone ALP and OC three clinical RIs for men based on age and three clinical RI for women based on age and menopausal status.
The RI for bone ALP and OC varies with age and sex and the BTMs are influenced differently by the two factors. Consequently, the need for establishing valid RIs is of great importance before the full potential of BTM can be used in clinical practice.
骨形成标志物骨碱性磷酸酶和骨钙素在许多临床情况下都有使用。因此，我们计算了这两种标志物的参考区间，并研究了它们如何受到性别和年龄等多种因素的影响。此外，我们为这两种标志物建立了临床相关的参考区间。
骨转换标志物（BTMs），骨碱性磷酸酶（骨 ALP）和骨钙素（OC）是常用的形成标志物。本研究的目的是在丹麦普通成年人群中建立这两种 BTM 的参考区间（RI）。
在丹麦健康 2006 年 5 年随访研究中，使用 iSYS（IDS Plc）自动分析仪在 2308 名参与者（54%为女性，年龄范围 24-76 岁）的血清样本中测量骨 ALP 和 OC。有骨质疏松症自我诊断或接受激素替代治疗的参与者排除在分析之外，而接受激素避孕药的参与者则包括在内。
男性骨 ALP 的几何均数和 95%RI 为 13.9μg/L（7.6-25.6），女性为 13.8μg/L（7.0-27.4），而男性 OC 为 16.0μg/L（7.5-34.4），女性为 18.6μg/L（8.1-42.9）。骨 ALP 水平随年龄增长而增加（β 1.004，p<0.001），而性别无影响。OC 水平随年龄增长而降低（β 0.998，p=0.009），随女性性别增加而增加（β 1.104，p<0.001）。根据我们的发现，我们提出了男性基于年龄的骨 ALP 和 OC 的三个临床 RI，以及女性基于年龄和绝经状态的三个临床 RI。
骨 ALP 和 OC 的 RI 随年龄和性别而变化，两种因素对 BTM 的影响不同。因此，在充分发挥 BTM 的潜力应用于临床实践之前，建立有效的 RI 非常重要。
