Schneider P F, Fischer M, Allolio B, Felsenberg D, Schröder U, Semler J, Ittner J R
Clinic for Nuclear Medicine, University of Würzburg, Würzburg, Germany.
J Bone Miner Res. 1999 Aug;14(8):1387-93. doi: 10.1359/jbmr.1999.14.8.1387.
In addition to the alendronate Osteoporosis Intervention Trial (FOSIT) core protocol 901-0A of 1908 enrolled patients, the use of peripheral quantitative computed tomography (pQCT) was explored for the assessment of response to therapy. Bone mineral and strength related parameters at two different sites at the distal radius were explored in a subset of the multicenter core study. One hundred and three patients were entered into the substudy and given either a daily dose of 10 mg of alendronate or placebo for 1 year. Measurements were done at months 0, 3, 6, and 12. Inclusion criteria were bone mineral density (BMD) measurements at the lumbar spine of -2 SD. The response to therapy was assessed by dual-energy X-ray absorptiometry in the lumbar spine and the hip, and by pQCT in the ultradistal and the shaft sites of the radius. In line with the FOSIT core study, alendronate increased BMD at the lumbar spine and the hip, and it decreased the serum biochemical markers of bone turnover. The substudy showed differences between the therapy and placebo group in trabecular bone density (8.4%, p = 0.095), in total density (6.8%, p = 0.009), and in the bone strength index (BSI) (15. 6 mm3, p = 0.037) at the ultradistal site due to treatment and no changes at the radius shaft. A significant correlation was observed between percentage changes from baseline in BMD of the lumbar spine, and in total density and bone strength at the ultradistal radius site in the treatment group, but not in the placebo group. Thus, the ultradistal radius site did respond to alendronate therapy. The increased bone density accompanied a significant gain in the BSI at the ultradistal site, a finding that might help explain the reduced wrist fractures in the alendronate Fracture Intervention Trial.
除了阿仑膦酸盐骨质疏松干预试验(FOSIT)核心方案中1908名入组患者的901-0A方案外,还探索了使用外周定量计算机断层扫描(pQCT)来评估治疗反应。在多中心核心研究的一个子集中,对桡骨远端两个不同部位的骨矿物质和强度相关参数进行了探索。103名患者进入该子研究,并给予每日10毫克阿仑膦酸盐或安慰剂,为期1年。在第0、3、6和12个月进行测量。纳入标准是腰椎骨矿物质密度(BMD)测量值为-2标准差。通过腰椎和髋部的双能X线吸收法以及桡骨超远端和骨干部位的pQCT来评估治疗反应。与FOSIT核心研究一致,阿仑膦酸盐增加了腰椎和髋部的BMD,并降低了骨转换的血清生化标志物。该子研究显示,治疗组和安慰剂组在超远端部位的小梁骨密度(8.4%,p = 0.095)、总密度(6.8%,p = 0.009)和骨强度指数(BSI)(15.6立方毫米,p = 0.037)存在差异,而桡骨干无变化。在治疗组中,观察到腰椎BMD相对于基线的百分比变化与超远端桡骨部位的总密度和骨强度之间存在显著相关性,但在安慰剂组中未观察到。因此,桡骨超远端部位确实对阿仑膦酸盐治疗有反应。骨密度增加伴随着超远端部位BSI的显著增加,这一发现可能有助于解释阿仑膦酸盐骨折干预试验中腕部骨折减少的原因。