Stepan Jan J, Burckhardt Peter, Hána Václav
3rd Department of Internal Medicine, Charles University School of Medicine, Faculty of Medicine, Prague, Czech Republic.
Bone. 2003 Oct;33(4):589-96. doi: 10.1016/s8756-3282(03)00205-9.
The aim of this study was to evaluate the effects of a 2-year treatment with intravenous ibandronate (2 mg every 3 months) and calcium (1000 mg daily) on bone mineral density (BMD) and bone markers in 14 patients with Klinefelter's syndrome who served as their own controls. During the follow-up of 5.9 years before the treatment was started, the mean rates of bone loss per year were 1.3, 0.9, and 0.6% in the lumbar spine, femoral neck, and total body, respectively. The rate of bone loss from the spine was significantly inversely related to both serum estradiol and testosterone. At the onset of treatment, the average age of the patients was 55.2 years (48-64 years), and T score, mean +/- SD, at the lumbar spine was -2.6 +/- 1.0. After 6 months, the mean serum CTX and PINP decreased by 39 and 55% below the pretreatment concentrations, respectively (P < 0.05). After 12 months of treatment, the patients gained mean +/- SD, 7.8 +/- 2.3% of BMD in the lumbar spine, 3.8 +/- 4.0% in the femoral neck, and 4.7 +/- 2.2% in the total body (P < 0.05). During the second year of treatment, all patients also received 700 IU of vitamin D daily. After 24 months of treatment, the patients gained 10.1 +/- 4.3% of BMD in the lumbar spine, 6.7 +/- 5.5% in the femoral neck, and 5.5 +/- 2.5% in the total body. The increase in BMD in the second year of ibandronate treatment was not significant. The rate of gain of BMD in the femoral neck was positively related to serum concentrations of testosterone and inversely related to 25-hydroxyvitamin D (P < 0.005). After the discontinuation of treatment, serum CTX and PINP increased to the pretreatment levels, and the lumbar spine and femur neck BMD decreased (P < 0.05). In conclusion, ibandronate was effective in increasing BMD at all sites, but the effects were adversely influenced by vitamin D insufficiency or deficiency. The overall changes in biochemical markers of bone remodeling were consistent with the antiresorptive effect of the drug.
本研究旨在评估静脉注射伊班膦酸钠（每3个月2毫克）和钙剂（每日1000毫克）进行为期2年的治疗，对14例克氏综合征患者骨密度（BMD）和骨标志物的影响，这些患者以自身作为对照。在开始治疗前的5.9年随访期间，腰椎、股骨颈和全身每年的平均骨丢失率分别为1.3%、0.9%和0.6%。脊柱的骨丢失率与血清雌二醇和睾酮均呈显著负相关。治疗开始时，患者的平均年龄为55.2岁（48 - 64岁），腰椎的T值，均值±标准差为 -2.6±1.0。6个月后，血清CTX和PINP的均值分别比治疗前浓度降低了39%和55%（P < 0.05）。治疗12个月后，患者腰椎的BMD均值±标准差增加了7.8±2.3%，股骨颈增加了3.8±4.0%，全身增加了4.7±2.2%（P < 0.05）。在治疗的第二年，所有患者还每日接受700 IU维生素D。治疗24个月后，患者腰椎的BMD增加了10.1±4.3%，股骨颈增加了6.7±5.5%，全身增加了5.5±2.5%。伊班膦酸钠治疗第二年BMD的增加不显著。股骨颈BMD的增加率与睾酮的血清浓度呈正相关，与25 - 羟基维生素D呈负相关（P < 0.005）。停药后，血清CTX和PINP升高至治疗前水平，腰椎和股骨颈BMD降低（P < 0.05）。总之，伊班膦酸钠在增加所有部位的BMD方面有效，但维生素D不足或缺乏对其效果产生不利影响。骨重塑生化标志物的总体变化与该药物的抗吸收作用一致。
