Ringe J D, Dorst A, Faber H, Ibach K
Medical Clinic 4, Klinikum Leverkusen, University of Cologne, 51375, Leverkusen, Germany.
Rheumatol Int. 2004 Mar;24(2):110-3. doi: 10.1007/s00296-003-0388-y. Epub 2003 Sep 10.
Our trial was a 3-year, open-label, prospective, comparative, clinical study comparing the effects of oral alendronate (ALN), 10 mg daily, and alfacalcidol (AC), 1 microg daily, on bone mineral density (BMD), fracture events, height, back pain, safety and tolerability in 134 men with established primary osteoporosis. All men received 500 mg calcium daily. BMD was measured at the lumbar spine and femoral neck using dual-energy X-ray absorptiometry (DXA). Spine radiographs were obtained at baseline and every 12 months thereafter, and were evaluated by a radiologist blinded to treatment assignment. At 3 years, AC-treated patients showed a significant mean increase of 3.5% in lumbar spine BMD, compared with a mean increase of 11.5% in men receiving ALN ( p<0.0001 between groups). The corresponding increases in femoral neck BMD were 2.3% and 5.8% for the AC and ALN groups, respectively ( p=0.0015 between groups). Over 3 years, new vertebral fractures occurred in 24.2% of the AC-treated patients and in 10.3% of the ALN-treated patients ( p=0.040). ALN-treated patients also had a significantly lower height loss. There were no between-group differences regarding nonvertebral fractures or changes in back pain. Both therapies were well tolerated, with a compliance rate >90%. We conclude that although AC has significant effects on BMD, ALN has greater effects on BMD and fracture efficacy.
我们的试验是一项为期3年的开放标签、前瞻性、对比性临床研究，比较每日口服10毫克阿仑膦酸钠（ALN）和每日口服1微克阿法骨化醇（AC）对134例已确诊原发性骨质疏松症男性患者的骨密度（BMD）、骨折事件、身高、背痛、安全性和耐受性的影响。所有男性患者每日均补充500毫克钙。使用双能X线吸收法（DXA）测量腰椎和股骨颈的骨密度。在基线时及此后每12个月拍摄脊柱X线片，并由对治疗分配不知情的放射科医生进行评估。3年后，接受AC治疗的患者腰椎骨密度平均显著增加3.5%，而接受ALN治疗的男性患者平均增加11.5%（组间p<0.0001）。AC组和ALN组股骨颈骨密度的相应增加分别为2.3%和5.8%（组间p=0.0015）。在3年期间，接受AC治疗的患者中有24.2%发生了新的椎体骨折，接受ALN治疗的患者中有10.3%发生了新的椎体骨折（p=0.040）。接受ALN治疗的患者身高损失也显著更低。在非椎体骨折或背痛变化方面，两组之间没有差异。两种治疗方法耐受性良好，依从率>90%。我们得出结论，虽然AC对骨密度有显著影响，但ALN对骨密度和骨折疗效的影响更大。
