Koev D, Todorova S, Diankov L, Khristova D, Tsachev K
Vutr Boles. 1988;27(2):117-22.
A clinical trial of the drug "Rocaltrol" was carried out on 16 patients with osteoporosis, II of them with menopause osteoporosis and 5 with steroid-induced osteoporosis. The mean age of the patients was 53.1 +/- 11.1 years. The mean daily dose of the drug was 0.46 +/- 0.08 mg/24h. The treatment lasted 6 months. All patients showed improvement of the general condition and of calcium balance. Reliable increase of the total calcium and phosphorus levels and of the 24-hour calcium urine excretion were established, the maximal values being at the end of the third month. The X-ray examination showed stabilization of the bone changes and lack of new compression fractures. It is supposed that the drug improves the intestinal resorption of calcium and phosphorus and suppresses the bone resorption. This is proved by the reliable decrease of serum alkaline phosphatase level after the 6 month treatment. In all patients clinical improvement was established with diminishing of the bone aches and retaining the body height before and after the treatment.
对16名骨质疏松患者进行了药物“罗钙全”的临床试验，其中2名患有绝经后骨质疏松，5名患有类固醇诱导的骨质疏松。患者的平均年龄为53.1±11.1岁。药物的平均日剂量为0.46±0.08毫克/24小时。治疗持续6个月。所有患者的一般状况和钙平衡均有改善。总钙、磷水平以及24小时尿钙排泄量均有可靠增加，最大值出现在第三个月末。X线检查显示骨改变稳定，无新的压缩性骨折。推测该药物可改善肠道对钙和磷的吸收，并抑制骨吸收。这在6个月治疗后血清碱性磷酸酶水平的可靠下降中得到了证实。所有患者均有临床改善，骨痛减轻，治疗前后身高保持不变。
