Sebba Anthony I, Bonnick Sydney Lou, Kagan Risa, Thompson Desmond E, Skalky Carol S, Chen Erluo, de Papp Anne E
Arthritis Associates, Palm Harbor, FL 34684, USA.
Curr Med Res Opin. 2004 Dec;20(12):2031-41. doi: 10.1185/030079904x16768.
The FACT study (Fosamax Actonel Comparison Trial) was a 1-year-head-to-head trial comparing the efficacy and tolerability of once weekly (DW) alendronate 70 mg and OW risedronate 35 mg for the treatment of postmenopausal osteoporosis. The present analysis was performed to determine the percentage of patients who had changes during the study in BMD and biochemical markers (BCMs) of bone turnover above or below specific cut-off points. A subgroup analysis of upper gastrointestinal (UGI) tolerability was also performed.
1053 postmenopausal women with low BMD were randomized to alendronate 70 mg OW (N = 520) or risedronate 35 mg OW (N = 533). The percentage of patients who had measured BMD gains > or = 3%, and > or = 5% after 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS) was analyzed. The percentage of patients who experienced any bone loss, and those with measured losses of 3% or more at these sites after 12 months, was determined. The percentage of patients achieving reductions in urinary N-telopeptide of type 1 human collagen (NTX) > or = 40%, and serum C-telopeptide of type 1 collagen (CTx) > or = 60%, bone-specific phosphatase (BSAP) > or = 30%, and N terminal propeptide of type 1 procollagen (P1NP) > or = 50% at 3 months and 12 months was also determined. Tolerability, based on adverse experience reporting, was evaluated in a subgroup of patients with history of UGI disorders at baseline.
A greater percentage of alendronate- than risedronate-treated patients had measured BMD gains (> or = 0%) (p < 0.05) at all sites at 12 months. Significantly more (p < 0.01) alendronate- than risedronate-treated patients had measured gains in BMD > or = 3% and > or = 5% at the hip trochanter, total hip, and LS spine. Significantly more (p < 0.05) risedronate- than alendronate-treated patients had an apparent loss of BMD (> 0% and > or = 3% loss) at the same sites. After 3 months, significantly (p < 0.001) more alendronate- than risedronate- treated patients achieved predefined reductions in all BCMs. Similar tolerability was demonstrated in both treatment groups, regardless of whether or not patients had a history of UGI disorders at baseline.
Significantly more alendronate- than risedronate-treated patients achieved predefined increases in BMD at 12 months and reductions in BCMs at 3 months. Significantly more risedronate- than alendronate-treated patients were classified as apparent 'non-responders' (i.e. experienced any bone loss) after 12 months of therapy. The tolerability profiles of the two medications were similar.
FACT研究（福善美与阿屈膦酸盐比较试验）是一项为期1年的直接对比试验，比较每周一次口服70毫克阿仑膦酸钠和每周一次口服35毫克利塞膦酸钠治疗绝经后骨质疏松症的疗效和耐受性。进行本次分析以确定在研究期间骨密度（BMD）和骨转换生化标志物（BCMs）变化高于或低于特定临界点的患者百分比。还进行了上消化道（UGI）耐受性的亚组分析。
1053名低骨密度的绝经后女性被随机分为每周一次口服70毫克阿仑膦酸钠组（N = 520）或每周一次口服35毫克利塞膦酸钠组（N = 533）。分析了在12个月后髋部大转子、全髋、股骨颈和腰椎（LS）处测量的骨密度增加≥3%和≥5%的患者百分比。确定了经历任何骨质流失的患者百分比，以及在这些部位12个月后测量的骨质流失达3%或更多的患者百分比。还确定了在3个月和12个月时1型人胶原蛋白尿N-端肽（NTX）降低≥40%、1型胶原蛋白血清C-端肽（CTx）降低≥60%、骨特异性磷酸酶（BSAP）降低≥30%以及1型前胶原N端前肽（P1NP）降低≥50%的患者百分比。基于不良事件报告，在基线时有上消化道疾病史的患者亚组中评估耐受性。
在12个月时，所有部位接受阿仑膦酸钠治疗的患者中骨密度增加（≥0%）的百分比高于接受利塞膦酸钠治疗的患者（p < 0.05）。在髋部大转子、全髋和腰椎处，接受阿仑膦酸钠治疗的患者骨密度增加≥3%和≥5%的比例显著高于接受利塞膦酸钠治疗的患者（p < 0.01）。在相同部位，接受利塞膦酸钠治疗的患者出现明显骨密度降低（>0%且≥3%降低）的比例显著高于接受阿仑膦酸钠治疗的患者（p < 0.05）。3个月后，接受阿仑膦酸钠治疗的患者在所有骨转换标志物方面达到预定义降低的比例显著高于接受利塞膦酸钠治疗的患者（p < 0.001）。两个治疗组的耐受性相似，无论患者在基线时是否有上消化道疾病史。
在12个月时，接受阿仑膦酸钠治疗的患者达到预定义骨密度增加的比例显著高于接受利塞膦酸钠治疗的患者，在3个月时骨转换标志物降低的比例也更高。在治疗12个月后，被归类为明显“无反应者”（即经历任何骨质流失）的接受利塞膦酸钠治疗的患者比例显著高于接受阿仑膦酸钠治疗的患者。两种药物的耐受性概况相似。
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