Calcitriol has been widely used in the management of osteoporosis, but its efficiency is a matter of controversy. It is not known whether combinations of calcitriol and antiresorptive agents such as etidronate and calcitonin are superior to calcitriol alone in the treatment of postmenopausal osteoporosis. To make this determination, 30 Turkish women with postmenopausal osteoporosis between 45 and 68 years of age were randomized to receive either intermittent cyclical etidronate (400 mg/day, for 14 days) followed by 60 days of cyclical calcitriol therapy 0.25 microg twice daily (group 1; n = 10), or calcitriol 0.25 microg twice daily (group 2; n = 10), or calcitriol 0.25 microg/day in combination with 100 IU intranasal salmon calcitonin taken every other day (group 3; n = 10) through a 1-year period. Bone mineral density (BMD) of lumbar spine (L2 to L4) was determined for each patient by dual-photon absorptiometry (153Gd) at baseline, after 6 months, and at the end of the study. There was no significant difference among groups with respect to mean spinal BMD at baseline, after 6, and after 12 months. No significant spinal BMD changes occurred in any group from baseline, after 6 months, and after 12 months. Four patients in groups 1 and 2 and five patients in group 3 developed hypercalcemia at least once during therapy. Hypercalciuria occurred at least once in 9, 10, and 7 patients in groups 1, 2, and 3, respectively. One patient in group 2 developed a renal stone at the end of the study. Mean urine hydroxyproline levels did not change significantly in any group with respect to baseline. The data suggest that one-year treatment with calcitriol, given either alone or in combination with antiresorptive agents, does not improve spinal BMD in Turkish women with postmenopausal osteoporosis, and is associated with a high rate of adverse events.

译文

骨化三醇已广泛用于骨质疏松症的治疗,但其效率仍存在争议。尚不清楚骨化三醇和抗吸收剂 (如依替膦酸盐和降钙素) 的组合在绝经后骨质疏松症的治疗中是否优于单独的骨化三醇。为了做出这一决定,30名年龄在45至68岁之间的绝经后骨质疏松症土耳其妇女被随机分配接受间歇性周期性依替膦酸盐 (400毫克/天,持续14天),然后接受60天的周期性骨化三醇治疗,0.25每天两次 (组1; n = 10),或骨化三醇0.25 microg每天两次 (组2; n = 10),或骨化三醇0.25 microg/天与100 IU鼻内鲑鱼降钙素组合,每隔一天服用 (组3; n = 10),持续1年。在基线,6个月后和研究结束时,通过双光子吸收法 (153Gd) 测定每位患者的腰椎 (L2至L4) 的骨矿物质密度 (BMD)。在基线,6个月后和12个月后,各组之间的平均脊柱BMD没有显着差异。从基线,6个月后和12个月后,任何组均未发生明显的脊柱BMD变化。第1组和第2组中的4名患者和第3组中的5名患者在治疗期间至少出现一次高钙血症。高钙尿症分别在第1、2和3组的9、10和7名患者中至少发生一次。第2组中的一名患者在研究结束时出现了肾结石。任何组的平均尿羟脯氨酸水平相对于基线没有明显变化。数据表明,单独或与抗吸收剂联合使用骨化三醇治疗一年不会改善土耳其绝经后骨质疏松症妇女的脊柱BMD,并且与不良事件的发生率很高有关。

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