Department of Clinical Biology, Bone and Cartilage Markers Laboratory, University of Liège, Liège, Belgium.
Osteoporos Int. 2010 Feb;21(2):233-41. doi: 10.1007/s00198-009-0940-z. Epub 2009 May 13.
Osteoporotic post-menopausal women patients in two randomised trials comparing the anti-fracture efficacy of strontium ranelate with placebo were separated into tertiles according to their baseline levels of biochemical markers of bone formation and resorption. The vertebral anti-fracture efficacy of strontium ranelate was shown to be independent of baseline bone turnover levels.
Bone turnover (BTO) levels vary among women at risk of osteoporotic fracture. Strontium ranelate is an anti-osteoporotic treatment increasing bone formation and reducing bone resorption. It was hypothesised that its anti-fracture efficacy would be independent of baseline BTO levels.
Post-menopausal women with osteoporosis from two pooled studies were stratified in tertiles according to baseline levels of two BTO markers: bone-specific alkaline phosphatase (b-ALP, n = 4995) and serum C-telopeptide cross-links (sCTX, n = 4891). Vertebral fracture risk was assessed over 3 years with strontium ranelate 2 g/day or placebo.
In the placebo group, relative risk of vertebral fractures increased with BTO tertiles by 32% and 24% for patients in the highest tertile for b-ALP and CTX, respectively, compared to those in the lowest tertile. In the strontium ranelate group, incidences of vertebral fracture did not differ significantly across BTO tertiles. Significant reductions in vertebral fractures with strontium ranelate were seen in all tertiles of both markers, with relative risk reductions of 31% to 47% relative to placebo. Risk reduction did not differ among tertiles (b-ALP: p = 0.513; sCTX: p = 0.290).
The vertebral anti-fracture efficacy of strontium ranelate was independent of baseline BTO levels. Strontium ranelate offers clinical benefits to women across a wide range of metabolic states.
在两项比较雷奈酸锶与安慰剂抗骨折疗效的随机试验中，将绝经后骨质疏松症女性患者根据其骨形成和骨吸收生化标志物的基线水平分为三分位。雷奈酸锶的椎体抗骨折疗效与基线骨转换水平无关。
骨转换（BTO）水平在有骨质疏松性骨折风险的女性中存在差异。雷奈酸锶是一种抗骨质疏松药物，可增加骨形成并减少骨吸收。假设其抗骨折疗效与基线 BTO 水平无关。
从两项汇总研究中，根据基线 2 项 BTO 标志物（骨碱性磷酸酶，b-ALP，n = 4995；血清 C 端肽交联，sCTX，n = 4891）水平将绝经后骨质疏松症女性患者分层为三分位。用雷奈酸锶 2 g/天或安慰剂治疗 3 年，评估椎体骨折风险。
在安慰剂组中，b-ALP 和 CTX 最高三分位的患者与最低三分位的患者相比，椎体骨折的相对风险分别增加了 32%和 24%。在雷奈酸锶组中，BTO 三分位之间的椎体骨折发生率无显著差异。在两种标志物的所有三分位中，雷奈酸锶治疗均显著降低椎体骨折发生率，与安慰剂相比，相对风险降低 31%至 47%。各三分位之间的风险降低无差异（b-ALP：p = 0.513；sCTX：p = 0.290）。
雷奈酸锶的椎体抗骨折疗效与基线 BTO 水平无关。雷奈酸锶为广泛代谢状态的女性提供了临床获益。
