Gürlek A, Bayraktar M, Gedik O
Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology, 06100-Ankara, Turkey.
Calcif Tissue Int. 1997 Jul;61(1):39-43. doi: 10.1007/s002239900291.
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.
骨化三醇已被广泛用于骨质疏松症的治疗，但其疗效仍存在争议。目前尚不清楚骨化三醇与抗吸收剂（如依替膦酸和降钙素）联合使用在治疗绝经后骨质疏松症方面是否优于单独使用骨化三醇。为了确定这一点，将30名年龄在45至68岁之间的土耳其绝经后骨质疏松症女性随机分为三组，分别接受以下治疗：组1（n = 10），先接受间歇周期性依替膦酸（400 mg/天，共14天）治疗，随后进行60天的周期性骨化三醇治疗，每日两次，每次0.25μg；组2（n = 10），每日两次，每次0.25μg骨化三醇；组3（n = 10），每日0.25μg骨化三醇与隔日100 IU鼻内鲑鱼降钙素联合使用，为期1年。在基线、6个月后和研究结束时，通过双能光子吸收法（153Gd）测定每位患者腰椎（L2至L4）的骨密度（BMD）。在基线、6个月和12个月后，各组之间的平均脊柱BMD没有显著差异。在任何一组中，从基线、6个月后到12个月后，脊柱BMD均未发生显著变化。组1和组2各有4名患者，组3有5名患者在治疗期间至少发生过一次高钙血症。组1、组2和组3分别有9名、10名和7名患者至少发生过一次高钙尿症。组2有1名患者在研究结束时出现肾结石。与基线相比，任何一组的平均尿羟脯氨酸水平均无显著变化。数据表明，对于土耳其绝经后骨质疏松症女性，单独使用骨化三醇或与抗吸收剂联合使用进行一年治疗，均不能改善脊柱BMD，且不良事件发生率较高。
