Department of Rheumatology, Auckland City Hospital, Auckland, New Zealand.
Osteoporos Int. 2013 Jan;24(1):349-54. doi: 10.1007/s00198-012-2117-4. Epub 2012 Aug 15.
We investigated whether baseline dietary calcium intake or vitamin D status modified the effects of zoledronate. Neither variable influenced the effect of zoledronate on bone mineral density, bone turnover, or risk of acute phase reaction, suggesting that co-administration of calcium and vitamin D supplements with zoledronate may not always be necessary.
Calcium and vitamin D supplements are often co-administered with bisphosphonates, but it is unclear whether they are necessary for therapeutic efficacy or minimizing side effects of bisphosphonates. We investigated whether baseline dietary calcium intake or vitamin D status modified the effect of zoledronate on bone mineral density (BMD) or bone turnover at 1 year, or the risk of acute phase reactions (APR).
Data were pooled from two trials of zoledronate in postmenopausal women without vitamin D deficiency in which calcium and vitamin D were not routinely administered. The cohort (zoledronate n = 154, placebo n = 68) was divided into subgroups by baseline dietary calcium intake (<800 vs. ≥800 mg/day) and vitamin D status [25-hydroxyvitamin D (25OHD) <50 vs. ≥50 nmol/L, and <75 nmol/L vs. ≥75 nmol/L] and treatment × subgroup interactions tested.
There were 52, 86, and 36 % of the zoledronate group and 64, 94, and 46 % of the placebo group that had dietary calcium intake ≥800 mg/day, 25OHD ≥50 nmol/L, and 25OHD ≥75 nmol/L, respectively. There were no significant interactions between treatment and either baseline dietary calcium or baseline vitamin D status for lumbar spine BMD, total hip BMD, the bone turnover markers P1NP and β-CTx, or the risk of an APR. There was also no three-way interaction between baseline dietary calcium intake, baseline vitamin D status, and treatment for any of these variables.
Baseline dietary calcium intake and vitamin D status did not alter the effects of zoledronate, suggesting that co-administration of calcium and vitamin D with zoledronate may not be necessary for individuals not at risk of marked vitamin D deficiency.
我们研究了基线饮食钙摄入量或维生素 D 状态是否会改变唑来膦酸的作用。
我们汇总了两项绝经后妇女中唑来膦酸的临床试验数据，这些妇女不伴有维生素 D 缺乏，且常规不给予钙和维生素 D 补充。根据基线饮食钙摄入量(<800 与≥800 mg/d)和维生素 D 状态[25-羟维生素 D(25OHD)<50 与≥50 nmol/L，以及<75 与≥75 nmol/L]将队列(唑来膦酸组 n=154，安慰剂组 n=68)分为亚组，并检验治疗与亚组间的交互作用。
唑来膦酸组中分别有 52%、86%和 36%，安慰剂组中分别有 64%、94%和 46%的患者饮食钙摄入量≥800 mg/d、25OHD≥50 nmol/L 和 25OHD≥75 nmol/L。治疗与基线饮食钙或基线维生素 D 状态之间无显著交互作用，用于评估的指标包括腰椎骨密度、全髋骨密度、骨转换标志物 P1NP 和 β-CTX，以及 APR 风险。对于这些变量，也未观察到基线饮食钙摄入量、基线维生素 D 状态与治疗之间的三向交互作用。
基线饮食钙摄入量和维生素 D 状态并未改变唑来膦酸的作用，这表明对于无明显维生素 D 缺乏风险的个体，唑来膦酸联合钙和维生素 D 治疗可能并非必需。
基线饮食钙摄入量或维生素 D 状态并未改变唑来膦酸对骨密度、骨转换或急性相反应风险的影响，这表明对于不伴有维生素 D 缺乏的患者，联合使用钙和维生素 D 补充剂可能不是必需的。
