Choi Hee-Jeong, Im Jee-Aee, Kim Sang-Hwan
Department of Family Medicine, Eulji University School of Medicine, Jung-Gu, Daejeon, Republic of Korea.
Maturitas. 2008 Jun 20;60(2):170-6. doi: 10.1016/j.maturitas.2008.05.003. Epub 2008 Jun 24.
High bone turnover, with bone resorption exceeding bone formation, is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention of bone loss. The objective of the current study was to determine the short-term efficacy of once-weekly low-dose alendronate in the prevention of bone loss, via bone turnover markers, in early postmenopausal Korean women with moderate bone loss.
This study involved a 12-week, randomized, double-blind clinical trial that compared the effects of placebo with alendronate 20mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400IU daily. We recruited 63 postmenopausal women (ranging from 50 to 65 years of age) with the lowest lumbar spine bone mineral density (BMD) at least 2.0 S.D. below the mean value for young healthy adults. BMD was measured at baseline and serum alkaline phosphatase (ALP), osteocalcin, C-terminal telopeptide of type I collagen (CTX), and osteoprotegerin (OPG) were measured at baseline and 12 weeks after treatment.
We randomly assigned 63 women to either placebo or alencronate 20 mg once a week for 3 months. Forty-nine women continued and completed all 3 months. After 3 months, bone resorption markers were significantly decreased in the alendronate group than in the placebo group: CTX -47.2% vs. 15% (p<0.01), ALP 1.6% vs. 25.9% (p=0.01), osteocalcin -29.2% vs. -13.6 (p=0.06). Women who received alendronate showed similar results to those who received placebo with regard to adverse events.
Once-weekly low-dose alendronate may be a cost-effective and safe method of suppressing bone turnover in early postmenopausal women with moderate bone loss.
高骨转换,即骨吸收超过骨形成,是绝经后骨质疏松症的主要机制。因此,抑制骨吸收是预防骨质流失的合理方法。本研究的目的是通过骨转换标志物来确定每周一次低剂量阿仑膦酸钠对绝经后早期有中度骨质流失的韩国女性预防骨质流失的短期疗效。
本研究为一项为期12周的随机双盲临床试验,比较了安慰剂与每周一次20mg阿仑膦酸钠的效果。所有受试者每天补充600mg钙和400IU维生素D。我们招募了63名绝经后女性(年龄在50至65岁之间),其腰椎骨密度最低值至少比年轻健康成年人的平均值低2.0个标准差。在基线时测量骨密度,并在基线和治疗12周后测量血清碱性磷酸酶(ALP)、骨钙素、I型胶原C末端肽(CTX)和骨保护素(OPG)。
我们将63名女性随机分为安慰剂组或每周一次20mg阿仑膦酸钠组,为期3个月。49名女性持续并完成了全部3个月的试验。3个月后,阿仑膦酸钠组的骨吸收标志物明显低于安慰剂组:CTX为-47.2% 对15%(p<0.01),ALP为1.6% 对25.9%(p=0.01),骨钙素为-29.2% 对-13.6(p=0.06)。在不良事件方面,接受阿仑膦酸钠治疗的女性与接受安慰剂治疗的女性结果相似。
对于绝经后早期有中度骨质流失的女性,每周一次低剂量阿仑膦酸钠可能是一种经济有效且安全的抑制骨转换的方法。