Stoch S Aubrey, Saag Kenneth G, Greenwald Maria, Sebba Anthony I, Cohen Stanley, Verbruggen Nadia, Giezek Hilde, West Joseph, Schnitzer Thomas J
Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ 07065.
J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.
Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy.
We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months.
At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline.
Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.
糖皮质激素诱导的骨质疏松症是最常见的医源性骨质疏松症形式。我们评估了每周一次双膦酸盐治疗在预防和治疗接受糖皮质激素治疗患者骨质流失方面的疗效和安全性。
我们进行了一项为期12个月的多中心、随机、双盲、安慰剂对照试验，治疗组和安慰剂组分别有114例和59例患者。参与者在随机分组时根据先前口服糖皮质激素治疗的持续时间进行分层。参与者接受每周一次70毫克阿仑膦酸钠（ALN OW）或安慰剂治疗；所有人均每日补充钙（1000毫克）和400国际单位维生素D。在基线、3、6、9和12个月时进行临床评估。
在12个月时，ALN OW组腰椎（2.45%）、转子（1.27%）、全髋（0.75%）和全身（1.70%）骨密度（BMD）较基线有显著的平均百分比增加。在12个月时比较ALN OW组与安慰剂组，观察到腰椎（治疗差异2.92%；p≤0.001）、转子（治疗差异1.66%；p = 0.007）和全髋（治疗差异1.19；p = 0.008）BMD从基线的平均百分比变化存在显著治疗差异。骨重塑的生化标志物也显示较基线有显著的平均百分比下降。
在接受糖皮质激素治疗的患者中，与基线相比，12个月期间ALN OW显著增加了腰椎、转子、全髋和全身的BMD。在12个月时，观察到腰椎、转子和全髋从基线的平均百分比变化与安慰剂相比存在显著治疗差异。
