Effects of alendronate sodium on severe osteodystrophy in postmenopausal patients with primary biliary cirrhosis: a pilot study

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• 作者：Floreani ; Annarosa ; Tizian ; Luisa ; Luisetto ; Giovanni ; Buda ; Andrea ; Mega ; Andrea ; Naccarato ; Remo
• 关键词：alendronate ; osteodystrophy ; primary biliary cirrhosis
• 刊名：Current Therapeutic Research
• 出版年：1998
• 期刊代码：75_0011393x
• 类别：med
• 出版时间：August, 1998
• 卷：59
• 期：8
• 页码：589-593
• 文件大小：343 K

摘要

Osteodystrophy is a major complication in primary biliary cirrhosis (PBC) and a significant problem for patients who require a liver transplant. Treatment for osteodystrophy has yet to be standardized. The goal of this pilot study was to assess the efficacy and tolerability of alendronate sodium, a potent specific inhibitor of osteoclast-mediated bone resorption. The study comprised 15 post-menopausal PBC patients (mean age, 64.25 ± 8.77 years) with severe osteodystrophy. Four patients had histologic stage II disease, 8 stage III, and 3 stage IV. All patients had a T score below 2, indicating a fracture risk of 60%. All patients received two courses of alendronate sodium (10 mg/d for 3 months, separated by a 2-month interval). The following variables were assessed at baseline and after 10 months: bone mineral density (BMD) (by dual-energy x-ray absorptiometry in the lumbar spine), calcium, sodium, potassium, creatinine, 25-hydroxyvitamin D, parathyroid hormone, and osteocalcin. No patients dropped out of the study, and therapy was well tolerated by all patients. At the end of treatment, BMD increased significantly compared with baseline (0.714 ± 0.115 g/cm² vs 0.740 ± 0.108 g/cm²). Although not statistically significant, a trend toward an increase in serum osteocalcin levels (1.4 ± 1.5 ng/mL vs 2.6 ± 1.4 ng/mL) was evident. These preliminary findings suggest that alendronate sodium may be helpful in treating severe osteodystrophy in postmenopausal patients with PBC. Larger, controlled trials using long-term treatment with alendronate sodium are needed to establish the efficacy and safety of this drug.