Bonnick Sydney, Broy Susan, Kaiser Fran, Teutsch Carol, Rosenberg Elizabeth, DeLucca Paul, Melton Mary
Clinical Research Center of North Texas, Denton, TX 76210, USA.
Curr Med Res Opin. 2007 Jun;23(6):1341-9. doi: 10.1185/030079907X188035.
Bisphosphonates such as alendronate are widely used for postmenopausal osteoporosis. Supplemental calcium is also generally recommended. This trial directly compares alendronate to supplemental calcium and examines the effect of calcium supplementation on alendronate treatment.
This 2-year, randomized, double-blind, multicenter trial enrolled healthy, postmenopausal women with low bone mineral density (BMD). Patients with a dietary calcium intake > or = 800 mg/day received daily vitamin D 400 IU and alendronate 10 mg/calcium-placebo, alendronate 10 mg/elemental calcium 1000 mg, or alendronate-placebo/calcium 1000 mg (2:2:1). Endpoints included BMD, bone turnover markers (BTMs), and adverse events.
Randomized patients (N = 701) were an average of 20.4 years postmenopausal. After 24 months, increases in lumbar spine BMD differed significantly between patients receiving calcium alone (0.8%) and either alendronate alone (5.6%) or alendronate + calcium (6.0%) (p < 0.001). Significant differences were also seen at the trochanter and femoral neck (p < 0.001). BTMs were significantly lower with alendronate-containing treatments than calcium alone (p < 0.001). Addition of calcium supplementation to alendronate did not significantly increase BMD compared to alendronate alone (p = 0.29 to 0.97), but did result in a statistically significant, though small, additional reduction in urinary NTx. Adverse events were similar among treatment groups. Limitations include no assessment of vitamin D levels and a discontinuation rate of approximately 30%, although discontinuation rates were similar among treatment groups.
In postmenopausal women with a daily intake of > or =800 mg calcium and 400 IU vitamin D, 24-month treatment with alendronate 10 mg daily with or without calcium 1000 mg resulted in significantly greater increases in BMD and reduction of bone turnover than supplemental calcium alone. Addition of supplemental calcium to alendronate treatment had no effect on BMD and resulted in a small, though statistically significant, additional reduction in NTx.
双膦酸盐类药物如阿仑膦酸钠被广泛用于治疗绝经后骨质疏松症。通常也建议补充钙剂。本试验直接比较阿仑膦酸钠与补充钙剂的效果，并研究补充钙剂对阿仑膦酸钠治疗效果的影响。
这项为期2年的随机、双盲、多中心试验纳入了健康的、绝经后骨密度低的女性。饮食中钙摄入量≥800毫克/天的患者每日服用400国际单位维生素D，并随机分为三组，分别接受阿仑膦酸钠10毫克/钙安慰剂、阿仑膦酸钠10毫克/元素钙1000毫克或阿仑膦酸钠安慰剂/钙1000毫克（比例为2:2:1）。观察终点包括骨密度、骨转换标志物（BTMs）和不良事件。
随机分组的患者（N = 701）平均绝经20.4年。24个月后，单纯补充钙剂的患者腰椎骨密度增加0.8%，单纯使用阿仑膦酸钠的患者增加5.6%，阿仑膦酸钠加钙剂的患者增加6.0%，三组之间差异有统计学意义（p < 0.001）。在大转子和股骨颈部位也观察到显著差异（p < 0.001）。含阿仑膦酸钠的治疗组骨转换标志物显著低于单纯补充钙剂组（p < 0.001）。与单纯使用阿仑膦酸钠相比，阿仑膦酸钠加钙剂并未显著增加骨密度（p = 0.29至0.97），但尿NTx有统计学意义的小幅额外降低。各治疗组不良事件相似。局限性包括未评估维生素D水平，停药率约为30%，尽管各治疗组停药率相似。
在每日摄入钙≥800毫克且维生素D 400国际单位的绝经后女性中，每日服用10毫克阿仑膦酸钠，无论是否加用1000毫克钙剂，治疗24个月后，骨密度增加和骨转换降低均显著大于单纯补充钙剂。阿仑膦酸钠治疗中加用补充钙剂对骨密度无影响，但尿NTx有小幅但有统计学意义的额外降低。
