Palomba Stefano, Orio Francesco, Manguso Francesco, Falbo Angela, Russo Tiziana, Tolino Achille, Tauchmanovà Libuse, Colao Annamaria, Doldo Patrizia, Mastrantonio Pasquale, Zullo Fulvio
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Osteoporos Int. 2005 Sep;16(9):1141-9. doi: 10.1007/s00198-005-1927-z. Epub 2005 Jun 1.
Patients with inflammatory bowel disease (IBD) have frequently a bone mineral density (BMD) significantly lower than age-matched healthy subjects. The low BMD observed in IBD patients is related also to a higher incidence of bone fractures. In this prospective randomized study we evaluated the effect of 1-year risedronate administration on bone mass and turnover, and on vertebral fractures in osteoporotic postmenopausal women with IBD in remission. Ninety osteoporotic postmenopausal women were randomized to receive oral risedronate 35 mg/week (risedronate group) or placebo tablets (placebo group; one tab/week). The duration of treatment was 12 months. At entry and after treatment, lumbar spine and hip BMD, and serum osteocalcin (OC) and urinary deoxypyridinoline/creatinine ratio (DPD-Cr) levels were evaluated. Vertebral fractures were assessed from thoracic and lumbar lateral and anterior-posterior spinal radiographs taken at baseline, and from lateral spinal radiographs taken at the end of the study. At study entry, no difference between groups was also detected in BMD and in bone turnover markers. At the end of the study, lumbar spine, trochanter and femoral neck BMD was significantly ( p <0.05) higher in comparison with baseline in the risedronate group, whereas a significant ( p <0.05) decrease was observed in the placebo group. For the same visit, a significant ( p <0.05) difference in lumbar spine, trochanter and femoral neck BMD was detected between groups. After 12-month follow-up, serum OC and urinary DPD-Cr levels were significantly ( p <0.05) lower and higher in comparison with basal values in risedronate and placebo group, respectively. At the same time, a significant ( p <0.05) difference in serum OC and urinary DPD-Cr levels was observed between groups. Throughout the study, the incidence of vertebral fractures was significantly ( p <0.05) lower in the risedronate group than in the placebo group (12.5% vs 34.1%). The relative risk (RR) to develop a new vertebral fracture after 1 year of risedronate administration was of 0.36 (95% confidence interval, 0.14-0.85). In conclusion, risedronate administration is an effective anti-osteoporotic treatment in osteoporotic postmenopausal women with IBD in remission.
炎症性肠病（IBD）患者的骨矿物质密度（BMD）通常显著低于年龄匹配的健康受试者。IBD患者中观察到的低骨密度也与较高的骨折发生率有关。在这项前瞻性随机研究中，我们评估了为期1年的利塞膦酸盐给药对处于缓解期的IBD绝经后骨质疏松女性的骨量、骨转换及椎体骨折的影响。90名绝经后骨质疏松女性被随机分为两组，分别接受每周口服35mg利塞膦酸盐（利塞膦酸盐组）或安慰剂片（安慰剂组；每周1片）。治疗持续时间为12个月。在入组时和治疗后，评估腰椎和髋部的骨密度、血清骨钙素（OC）以及尿脱氧吡啶啉/肌酐比值（DPD-Cr）水平。通过在基线时拍摄的胸椎和腰椎侧位及前后位脊柱X线片以及在研究结束时拍摄的脊柱侧位X线片来评估椎体骨折情况。在研究入组时，两组在骨密度和骨转换标志物方面也未检测到差异。在研究结束时，利塞膦酸盐组的腰椎、大转子和股骨颈骨密度与基线相比显著升高（p<0.05），而安慰剂组则观察到显著降低（p<0.05）。对于同一次访视，两组在腰椎、大转子和股骨颈骨密度方面检测到显著差异（p<0.05）。经过12个月的随访，利塞膦酸盐组和安慰剂组的血清OC和尿DPD-Cr水平与基础值相比分别显著降低（p<0.05）和升高（p<0.05）。同时，两组在血清OC和尿DPD-Cr水平方面观察到显著差异（p<0.05）。在整个研究过程中，利塞膦酸盐组的椎体骨折发生率显著低于安慰剂组（12.5%对34.1%，p<0.05）。服用利塞膦酸盐1年后发生新椎体骨折的相对风险（RR）为0.36（95%置信区间，从0.14至0.85）。总之，对于处于缓解期的IBD绝经后骨质疏松女性，服用利塞膦酸盐是一种有效的抗骨质疏松治疗方法。
