Fujita Takuo, Orimo Hajime, Inoue Tetsuo, Kaneda Kiyoshi, Sakurai Minoru, Morita Rikushi, Yamamoto Kichizo, Sugioka Yoichi, Inoue Akio, Takaoka Kunio, Yamamoto Itsuo, Hoshino Yuichi, Kawaguchi Hiroshi
Calcium Research Institute, Katsuragi Hospital, 250 Makamicho, Kishiwada, Osaka 596-0842, Japan.
J Bone Miner Metab. 2007;25(2):130-7. doi: 10.1007/s00774-006-0738-4. Epub 2007 Feb 26.
As inhibitors of bone resorption, bisphosphonates and vitamin D derivatives have been extensively used for the treatment of osteoporosis in various parts of the world, but the clinical effects of these two groups of agents have rarely been compared in detail. A multicenter, prospective, double-blind controlled study was started comparing the effects of etidronate and alfacalcidol (1-alpha-hydroxycholecalciferol) in 414 patients with established osteoporosis from 36 centers. Among these patients, 135 were given 400 mg etidronate daily at bedtime for 2 weeks followed by 10 weeks off treatment, and this cycle was repeated four times along with a placebo indistinguishable from the alfacalcidol capsule daily throughout the 48 weeks of study (Group A, High Dose Etidronate Group). In 133 patients, 200 mg etidronate was used instead of 400 mg (Group B, Low Dose Etidronate Group). In 138 patients, 1 microg alfacalcidol was given daily throughout the 48-week study period along with a placebo indistinguishable from the etidronate tablet in four separate periods of 2 weeks (Group C, Control Group). Dual-energy X-ray absorptiometry of the lumbar spine (L2-L4) was performed before the beginning of the study and every 12 weeks thereafter. Changes in spinal deformity were also assessed based on the lateral thoracic and lumbar spine X-ray films taken before and after the study. The lumbar spine bone mineral density (BMD) changes were +3.4% +/- 0.6% (mean +/- SEM) in Group A, +2.4% +/- 0.5% in Group B, and -0.5% +/- 0.4% in Group C, the former two being significantly higher than the last. New occurrence of spinal compression fracture was also significantly reduced in Group A compared to Group C. In patients without previous fracture at entry, incident fracture was 10.2% in Group C, but 0% in Groups A and B. In patients with prevalent fracture at entry, corresponding figures were 21.5% (Group C), 12.0% (Group A), and 13.2% (Group B), respectively. Alfacalcidol maintained lumbar spine BMD, preventing a decrease for 48 weeks, and etidronate significantly increased it further, demonstrating its usefulness in the treatment of established osteoporosis.
作为骨吸收抑制剂，双膦酸盐和维生素D衍生物在世界各国已被广泛用于治疗骨质疏松症，但这两类药物的临床效果很少进行详细比较。一项多中心、前瞻性、双盲对照研究开始了，该研究比较了依替膦酸和阿法骨化醇（1α-羟基胆钙化醇）对来自36个中心的414例确诊骨质疏松症患者的影响。在这些患者中，135例患者在睡前每日服用400mg依替膦酸，持续2周，随后停药10周，这个周期重复4次，同时在整个48周的研究期间每日服用与阿法骨化醇胶囊难以区分的安慰剂（A组，高剂量依替膦酸组）。133例患者使用200mg依替膦酸代替400mg（B组，低剂量依替膦酸组）。138例患者在整个48周的研究期间每日服用1μg阿法骨化醇，在四个单独的2周期间同时服用与依替膦酸片难以区分的安慰剂（C组，对照组）。在研究开始前及之后每12周进行腰椎（L2-L4）双能X线吸收测定。还根据研究前后拍摄的胸腰椎侧位X线片评估脊柱畸形的变化。A组腰椎骨密度（BMD）变化为+3.4%±0.6%（平均值±标准误），B组为+2.4%±0.5%，C组为-0.5%±0.4%，前两组明显高于最后一组。与C组相比，A组脊柱压缩性骨折的新发病例也显著减少。在入组时无既往骨折的患者中，C组的新发骨折率为10.2%，而A组和B组为0%。在入组时有既往骨折的患者中，相应的数据分别为21.5%（C组）、12.0%（A组）和13.2%（B组）。阿法骨化醇维持腰椎骨密度，在48周内防止其下降，而依替膦酸使其进一步显著增加，证明其在治疗确诊骨质疏松症方面的有效性。
