论文部分内容阅读
Bone loss is a well-recognized complication of primary biliary cirrhosis (PBC). Although it has been suggested that alendronate might improve bone mineral density (BMD) in PBC, no randomized placebo-controlled trial has been conducted. The primary aim of this study was to compare the effects of alendronate versus p lacebo on BMD and biochemical measurements of bone turnover in patients with PBC -associated bone loss. We conducted a double- blinded, randomized, placebo-controlled trial. Patients with a PBC and BMD t score of less than -1.5 were randomized to receive 70 mg per week of alendronat e or placebo over 1 year. BMD of the lumbar spine and proximal femur were measur ed at entry and at 1 year. Changes from baseline in BMD and biochemical measurem ents of bone turnover were assessed. Thirty-four patients were enrolled. Sevent een patients were randomized to each arm. After 1 year, a significantly larger i mprovement (P = .005) in spine BMD was observed in the alendronate group (0.09 ±0.03 g/cm2 SD from baseline) comparedwith the placebo group (-0.003±0.02 g/c m2 SD from baseline). A larger improvement (P = .046)was also observed in the fe moral BMD of alendronate patients versus placebo. BMD changes were independent o f concomitant estrogen therapy. The rate of adverse effects was similar in both groups. In conclusion, in patients with PBC-related bone loss, alendronate sign ificantly improves BMD compared with placebo. Although in this study oral alendr onate appears to be well tolerated in patients with PBC, larger studies are need ed to formally evaluate safety.
Bone loss is a well-recognized complication of primary biliary cirrhosis (PBC). Although it has been suggested that alendronate might improve bone mineral density (BMD) in PBC, no randomized placebo-controlled trial has been conducted. The primary aim of this study was to compare the effects of alendronate versus p lacebo on BMD and biochemical measurements of bone turnover in patients with PBC -associated bone loss. We conducted a double-blinded, randomized, placebo-controlled trial. Patients with a PBC and BMD t score of less than -1.5 were randomized to receive 70 mg per week of alendronate e or placebo over 1 year. BMD of the lumbar spine and proximal femur were measur ed at entry and at 1 year. Changes from baseline in BMD and biochemical measure of ents of bone Thirty-four patients were enrolled. Sevent een patients were randomized to each arm. After 1 year, a significantly larger i mprovement (P = .005) in spine BMD was observed in the alendronate group (0. 09 ± 0.03 g / cm2 SD from baseline) compared with the placebo group (-0.003 ± 0.02 g / c m2 SD from baseline). A larger improvement (P = .046) was also observed in the fe moral BMD of alendronate patients versus placebo . The conclusion is independent of concomitant estrogen therapy. The rate of adverse effects was similar in both groups. In conclusion, in patients with PBC-related bone loss, alendronate significantly improves BMD compared with placebo. to be well tolerated in patients with PBC, larger studies are need ed to formally evaluate safety.