Meunier P J, Vignot E, Garnero P, Confavreux E, Paris E, Liu-Leage S, Sarkar S, Liu T, Wong M, Draper M W
Service de Rhumatologie et de Pathologie Osseuse, Hôpital Edouard Herriot, Lyon, France.
Osteoporos Int. 1999;10(4):330-6. doi: 10.1007/s001980050236.
Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effects of raloxifene on BMD, biochemical markers of bone metabolism and serum lipids in postmenopausal women with low bone density or osteoporosis. This Phase II, multicenter, 24-month, double-masked study assessed the efficacy and safety of raloxifene in 129 postmenopausal women (mean age +/- SD: 60.2 +/- 6.7 years) with osteoporosis or low bone density (baseline mean lumbar spine BMD T-score: -2.8). Women were randomly assigned to one of three treatment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or 150 mg/day raloxifene-HCL (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D3. At 24 months, BMD was significantly increased in the lumbar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and total hip (+1.6%) in the RLX 60 group compared with the placebo group (p < 0.05). The RLX 150 group had increases in BMD similar to those observed with RLX 60. A greater percentage of raloxifene-treated patients, compared with those receiving placebo, had increased BMD (p < 0.05). Serum bone-specific alkaline phosphatase activity, serum osteocalcin, and urinary type I collagen:creatinine ratio were significantly decreased in the RLX-treated groups, compared with the placebo group (p < 0.01). RLX 60 treatment significantly decreased serum levels of triglycerides, and total- and LDL-cholesterol levels (p < 0.01). The rates of patient discontinuation and adverse events were not significantly different among groups. In this study, raloxifene increased bone density, decreased bone turnover, and improved the serum lipid profile with minimal adverse events, and may be a safe and effective treatment for postmenopausal women with osteoporosis or low bone density.
雷洛昔芬是一种选择性雌激素受体调节剂（SERM），已被证明可提高健康绝经后女性的骨矿物质密度（BMD）并改善血脂水平。本研究的目的是检验雷洛昔芬对骨密度低或患有骨质疏松症的绝经后女性的骨密度、骨代谢生化标志物及血脂的影响。这项为期24个月的多中心II期双盲研究评估了雷洛昔芬对129名患有骨质疏松症或骨密度低的绝经后女性（平均年龄±标准差：60.2±6.7岁，基线腰椎骨密度T值：-2.8）的疗效和安全性。女性被随机分配到三个治疗组之一：安慰剂组、60毫克/天雷洛昔芬盐酸盐（RLX 60）组或150毫克/天雷洛昔芬盐酸盐（RLX 150）组，并同时每日服用1000毫克钙和300国际单位维生素D3。24个月时，与安慰剂组相比，RLX 60组的腰椎（+3.2%）、股骨颈（+2.1%）、大转子（+2.7%）和全髋（+1.6%）骨密度显著增加（p<0.05）。RLX 1
