Man Z, Otero A B
Centro de Endocrinología T.I.E.M.P.O., Buenos Aires, Argentina.
Medicina (B Aires). 1997;57 Suppl 1:32-6.
A sample of 871.3 patients/year was conformed by 205 postmenopausal women, aged 64.8 +/- 18.2 years (mean +/- SD), followed up during 51 +/- 12 months. All have osteoporosis, diagnosis assessed through radiological findings of at least one atraumatic fracture or vertebral crush ("severe osteoporosis" according to the new WHO classification). Each woman received 100 mg/day oral pamidronate (enteric coated soft gelatin capsules), half an hour before breakfast. Additional calcium and vitamin D were supplemented as follows: Total daily calcium = 1 g provided by diet and/or calcium carbonate. Vitamin D equivalent to 400-1200 IU/day. All patients were recommended to improve their physical activity, at least by walking exercise. Clinical examination radiological, bone mineral density (BMD) and biochemical studies were periodically performed. But, fracture indicence was the end-point of the study. Same was related to the 1,673 fall episodes recorded in the sample. In addition, height loss, lumbar BMD, proximal femur BMD, are also reported. Data has been cross-sectional collected in March 1995. All patients improved the symptomatology, specifically pain. This, and the good tolerability of the treatments proved to be considerably favorable for their compliance. Within the observation period, only 12 patients decreased their height (5.85%; mean = 0.85 cm; range = 0.5-2.0 cm). Lumbar spine BMD increased in 90% of 48 women. Mean gain after 2 years was 5.3 +/- 1.0% (p < 0.001). Proximal femur increased in 78% of other 32 women. Mean gain 6.3 +/- 0.7% (p < 0.001) after 2 years. A total of 78 new fractures were recorded, 47 vertebral crush, 29 forearm fractures and 2 hip fractures. Its incidence related to the fall episodes was of 2.8; 1.7 and 0.12% respectively. When compared with a historical estimated data, from an untreated population (Cummings SR et al, 1994), both, the total number of new fractures and the new hip fractures were significantly lower (p < 0.01) in our treated population than the reference data. Pamidronate, in oral doses of 100 mg/day, adequately supplemented with calcium and vitamin D, proved to be effective and a well tolerated therapy. The low rate of height's loss, BMD significant increases in subgroups of patients and the low rate of new fractures, strongly support the use of the compound to treat severe osteoporotic women. To our knowledge, this is the first time, that the new fracture incidence is related to the fall frequency reported in a bisphosphonate treated sample.
每年871.3例患者的样本由205名绝经后女性组成，年龄为64.8±18.2岁（均值±标准差），随访时间为51±12个月。所有患者均患有骨质疏松症，通过至少一处非创伤性骨折或椎体压缩的放射学检查结果进行诊断（根据世界卫生组织新分类为“严重骨质疏松症”）。每位女性每天早餐前半小时口服100毫克帕米膦酸盐（肠溶包衣软胶囊）。额外补充钙和维生素D如下：每日总钙量=饮食和/或碳酸钙提供1克。维生素D相当于400 - 1200国际单位/天。所有患者均被建议增加身体活动，至少通过步行锻炼。定期进行临床检查、放射学检查、骨矿物质密度（BMD）和生化研究。但是，骨折发生率是研究的终点。这与样本中记录的1673次跌倒事件相关。此外，还报告了身高降低、腰椎BMD、股骨近端BMD。数据于1995年3月进行横断面收集。所有患者的症状均有改善，尤其是疼痛。这一点以及治疗的良好耐受性被证明对患者的依从性非常有利。在观察期内，只有12名患者身高降低（5.85%；均值=0.85厘米；范围=0.5 - 2.0厘米）。48名女性中有90%的腰椎BMD增加。2年后平均增加5.3±1.0%（p<0.001）。其他32名女性中有78%的股骨近端BMD增加。2年后平均增加6.3±0.7%（p<0.001）。共记录了78例新骨折，47例椎体压缩骨折，29例前臂骨折和2例髋部骨折。其发生率与跌倒事件的发生率分别为2.8%、1.7%和0.12%。与未治疗人群的历史估计数据（Cummings SR等人，1994年）相比，我们治疗人群中的新骨折总数和新髋部骨折数均显著低于参考数据（p<0.01）。每日口服100毫克剂量的帕米膦酸盐，并充分补充钙和维生素D，被证明是一种有效且耐受性良好的治疗方法。身高降低率低、患者亚组中BMD显著增加以及新骨折率低，有力地支持了使用该化合物治疗严重骨质疏松症女性。据我们所知，这是首次将新骨折发生率与双膦酸盐治疗样本中报告的跌倒频率相关联。
