de Papp Anne E, Bone Henry G, Caulfield Michael P, Kagan Risa, Buinewicz Anna, Chen Erluo, Rosenberg Elizabeth, Reitz Richard E
Merck and Co., Inc., 351 N. Sumneytown Pike, North Wales, PA 19454-2505, USA.
Bone. 2007 May;40(5):1222-30. doi: 10.1016/j.bone.2007.01.008. Epub 2007 Jan 24.
Biochemical markers of bone turnover (BTMs) provide useful information in the diagnosis and management of metabolic bone diseases. Currently, there exist few published reference ranges for bone markers in healthy premenopausal women using the newer, automated assays of bone turnover. This cross-sectional study of healthy premenopausal women was performed to determine reference ranges for four different markers of bone turnover and to compare reference ranges in users and non-users of oral contraceptives (OCs).
Urinary N-telopeptide of type 1 collagen (NTX) was determined from fasting second morning-void urine of healthy premenopausal women. In addition, fasting serum was collected for determination of C-telopeptide of type I collagen (CTX), bone-specific alkaline phosphatase (bone ALP), and N-terminal propeptide of type 1 procollagen (PINP). Subjects underwent central dual energy X-ray absorptiometry and completed a questionnaire regarding medical history and activities known to affect bone health.
Serum and urine samples were collected from 237 healthy premenopausal women (119 OC users and 118 non-users) between the ages of 28 and 45 years. The mean age of subjects was 37 years, with a mean bone mineral density T-score of -0.1 at the lumbar spine and 0.0 at the total hip. Logarithmic transformation produced normal distributions for all markers but NTX. Mid-95% ranges for each marker were generally consistent with those reported by manufacturers. For each BTM examined, values were skewed toward the lower end of the range. Median NTX levels for OC users and non-users were 16.0 and 29.0 nmol/mmol creatinine, respectively. The mid-95% ranges for NTX in OC users and non-users were 3-60 and 4-64 nmol/mmol creatinine, respectively. Median levels of CTX, bone ALP, and PINP were also lower in OC users than non-users. The mean level of each BTM was significantly lower in OC users than non-users (P<0.01), whereas reference ranges (geometric mean+/-2 SD) were somewhat similar for the two groups.
Values obtained from this well-characterized population provide reference ranges for BTMs in healthy premenopausal women. Median and mean BTM levels for OC users were consistently lower compared with non-users; thus, separate reference ranges are required for these two groups of premenopausal women. The relevance of premenopausal reference ranges for postmenopausal women remains uncertain.
骨转换生化标志物(BTMs)在代谢性骨病的诊断和管理中提供了有用信息。目前,使用更新的骨转换自动化检测方法,健康绝经前女性骨标志物的已发表参考范围较少。本横断面研究对健康绝经前女性进行,以确定四种不同骨转换标志物的参考范围,并比较口服避孕药(OCs)使用者和非使用者的参考范围。
从健康绝经前女性空腹第二晨尿中测定尿I型胶原N-端肽(NTX)。此外,采集空腹血清以测定I型胶原C-端肽(CTX)、骨特异性碱性磷酸酶(骨ALP)和I型前胶原N-端前肽(PINP)。受试者接受中心双能X线吸收测定,并完成一份关于病史和已知影响骨骼健康活动的问卷。
收集了237名年龄在28至45岁之间的健康绝经前女性(119名OC使用者和118名非使用者)的血清和尿液样本。受试者的平均年龄为37岁,腰椎的平均骨密度T值为-0.1,全髋为0.0。对数转换使除NTX外的所有标志物呈正态分布。每个标志物的95%中位数范围通常与制造商报告的范围一致。对于所检测的每个BTM,数值倾向于范围的下限。OC使用者和非使用者的NTX中位数水平分别为16.0和29.0 nmol/mmol肌酐。OC使用者和非使用者的NTX的95%中位数范围分别为3-60和4-64 nmol/mmol肌酐。OC使用者的CTX、骨ALP和PINP中位数水平也低于非使用者。每个BTM的平均水平在OC使用者中显著低于非使用者(P<0.01),而两组的参考范围(几何平均数±2标准差)有些相似。
从这一特征明确的人群中获得的值为健康绝经前女性的BTMs提供了参考范围。OC使用者的BTM中位数和平均水平与非使用者相比始终较低;因此,这两组绝经前女性需要单独的参考范围。绝经前参考范围对绝经后女性的相关性仍不确定。