Rosen Clifford J, Hochberg Marc C, Bonnick Sydney L, McClung Michael, Miller Paul, Broy Susan, Kagan Risa, Chen Erluo, Petruschke Richard A, Thompson Desmond E, de Papp Anne E
Maine Center of Osteoporosis Research and Education and St Joseph Hospital, Bangor, Maine 04401, USA.
J Bone Miner Res. 2005 Jan;20(1):141-51. doi: 10.1359/JBMR.040920. Epub 2004 Sep 29.
Once-weekly alendronate 70 mg and once-weekly risedronate 35 mg are indicated for the treatment of postmenopausal osteoporosis. These two agents were compared in a 12-month head-to-head trial. Greater gains in BMD and greater reductions in markers of bone turnover were seen with alendronate compared with risedronate with similar tolerability.
The nitrogen-containing bisphosphonates, alendronate and risedronate, are available in once-weekly (OW) formulations for the treatment of postmenopausal osteoporosis. A 12-month, head-to-head study was performed to compare these agents in the treatment of postmenopausal women with low BMD.
A total of 1053 patients from 78 U.S. sites were randomized to OW alendronate 70 mg (N = 520) or risedronate 35 mg (N = 533), taken in the morning after fasting. Endpoints included BMD changes over 6 and 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS); percent of patients with predefined levels of change in trochanter and LS BMD at 12 months; and change in biochemical markers of bone turnover at 3, 6, and 12 months. Tolerability was evaluated by adverse experience (AE) reporting.
Significantly greater increases in hip trochanter BMD were seen with alendronate (3.4%) than risedronate (2.1%) at 12 months (treatment difference, 1.4%; p < 0.001) as well as 6 months (treatment difference, 1.3%; p < 0.001). Significantly greater gains in BMD were seen with alendronate at all BMD sites measured (12-month difference: total hip, 1.0%; femoral neck, 0.7%; LS, 1.2%). Significant differences were seen as early as 6 months at all sites. A greater percentage of patients had > or =0% (p < 0.001) and > or =3% (p < 0.01) gain in trochanter and spine BMD at 12 months with alendronate than risedronate. Significantly greater (p < 0.001) reductions in all biochemical markers of bone turnover occurred with alendronate compared with risedronate by 3 months. No significant differences were seen between treatment groups in the incidence of upper gastrointestinal AEs or AEs causing discontinuation.
In this 12-month, head-to-head trial of alendronate and risedronate, given in accordance with the approved OW regimens for treatment of osteoporosis in postmenopausal women, alendronate produced greater gains in BMD and greater reductions in markers of bone turnover than risedronate. The greater antiresorptive effect of alendronate was seen as early as 3 months, and the tolerability profiles were similar.
每周一次阿仑膦酸钠70毫克和每周一次利塞膦酸钠35毫克适用于治疗绝经后骨质疏松症。在一项为期12个月的直接对比试验中对这两种药物进行了比较。与利塞膦酸钠相比，阿仑膦酸钠在骨密度增加和骨转换标志物降低方面效果更显著，且耐受性相似。
含氮双膦酸盐阿仑膦酸钠和利塞膦酸钠有每周一次（OW）的剂型用于治疗绝经后骨质疏松症。进行了一项为期12个月的直接对比研究，以比较这两种药物对绝经后低骨密度女性的治疗效果。
来自美国78个地点的1053例患者被随机分为服用每周一次阿仑膦酸钠70毫克（N = 520）或利塞膦酸钠35毫克（N = 533），于空腹后的早晨服用。终点指标包括6个月和12个月时髋部大转子、全髋、股骨颈和腰椎（LS）的骨密度变化；12个月时大转子和LS骨密度达到预定变化水平的患者百分比；以及3个月、6个月和12个月时骨转换生化标志物的变化。通过不良事件（AE）报告评估耐受性。
12个月时，阿仑膦酸钠组髋部大转子骨密度显著增加（3.4%），高于利塞膦酸钠组（2.1%）（治疗差异为1.4%；p < 0.001），6个月时也是如此（治疗差异为1.3%；p < 0.001）。在所有测量的骨密度部位，阿仑膦酸钠组的骨密度增加均显著更大（12个月差异：全髋为1.0%；股骨颈为0.7%；LS为1.2%）。所有部位在6个月时就出现了显著差异。12个月时，阿仑膦酸钠组大转子和脊柱骨密度增加≥0%（p < 0.001）和≥3%（p < 0.01）的患者百分比高于利塞膦酸钠组。与利塞膦酸钠相比，阿仑膦酸钠在3个月时所有骨转换生化标志物的降低均显著更大（p < 0.001）。治疗组在上消化道不良事件或导致停药的不良事件发生率方面无显著差异。
在这项为期12个月的阿仑膦酸钠和利塞膦酸钠直接对比试验中，按照批准的用于治疗绝经后女性骨质疏松症的每周一次方案给药，阿仑膦酸钠在骨密度增加和骨转换标志物降低方面比利塞膦酸钠效果更显著。阿仑膦酸钠更强的抗吸收作用在3个月时就已显现，且耐受性相似。
