Department of Public Health, Epidemiology and Health Economics, CHU Sart-Tilman, University of Liège, Bât B23, 4000 Liège, Belgium.
Osteoporos Int. 2010 Jun;21(6):1031-6. doi: 10.1007/s00198-009-1078-8. Epub 2009 Oct 8.
From two randomised controlled trials, it is shown that 3-month changes in biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) were associated with 3-year bone mineral density (BMD) changes, but not fracture incidence in patients treated with strontium ranelate.
The purpose of this study was to assess if short-term change in biochemical markers of bone remodelling is associated with long-term BMD change and fracture incidence observed during treatment with strontium ranelate.
From the SOTI and TROPOS trials, bone-specific alkaline phosphatase (BALP), C-terminal propeptide of type I procollagen (PICP), serum C-terminal telopeptides (S-CTX) and urine N-terminal telopeptides of type I collagen (U-NTX) were assessed at baseline and after 3 months.
Two thousand three hundred seventy-three women were included in this study. Multiple regression analysis showed that 3-month changes in PICP and BALP but not s-CTX I nor s-NTX I were significantly (p < 0.001) associated with 3-year BMD changes at the lumbar spine and the femoral neck. Changes in s-CTX I, PICP and BALP were significantly associated with change in total proximal femur BMD. Changes in biochemical markers explain less than 8% of the BMD changes. The 3-month changes in BALP, PICP s-CTX I and s-NTX I were not significantly associated with fracture incidence.
Short-term changes in biochemical markers of bone formation are associated with future BMD changes in patients treated with strontium ranelate, suggesting a bone-forming activity of this treatment, but are not appropriate to monitor the efficacy of strontium ranelate at the individual level.
两项随机对照试验表明，骨形成的生化标志物（骨碱性磷酸酶和 I 型前胶原 C 端肽）在 3 个月时的变化与 3 年时的骨密度（BMD）变化相关，但与雷奈酸锶治疗患者的骨折发生率无关。
本研究旨在评估在雷奈酸锶治疗期间，骨重建生化标志物的短期变化是否与长期 BMD 变化和观察到的骨折发生率相关。
在 SOTI 和 TROPOS 试验中，基线和 3 个月时检测骨碱性磷酸酶（BALP）、I 型前胶原 C 端肽（PICP）、血清 C 端肽（S-CTX）和尿 I 型胶原 N 端肽（U-NTX）。
本研究共纳入 2373 名女性。多元回归分析显示，3 个月时 PICP 和 BALP 的变化（p < 0.001）与腰椎和股骨颈的 3 年 BMD 变化显著相关，但 S-CTX I 和 s-NTX I 无显著相关性。s-CTX I、PICP 和 BALP 的变化与全髋 BMD 的变化显著相关。生化标志物的变化仅能解释不到 8%的 BMD 变化。BALP、PICP、s-CTX I 和 s-NTX I 的 3 个月变化与骨折发生率无显著相关性。
雷奈酸锶治疗患者的骨形成生化标志物短期变化与未来的 BMD 变化相关，提示该治疗具有成骨活性，但不适合个体水平监测雷奈酸锶的疗效。
