Orwoll E, Ettinger M, Weiss S, Miller P, Kendler D, Graham J, Adami S, Weber K, Lorenc R, Pietschmann P, Vandormael K, Lombardi A
Oregon Health Sciences University, Portland 97201, USA.
N Engl J Med. 2000 Aug 31;343(9):604-10. doi: 10.1056/NEJM200008313430902.
Despite its association with disability, death, and increased medical costs, osteoporosis in men has been relatively neglected as a subject of study. There have been no large, controlled trials of treatment in men.
In a two-year double-blind trial, we studied the effect of 10 mg of alendronate or placebo, given daily, on bone mineral density in 241 men (age, 31 to 87 years; mean, 63) with osteoporosis. Approximately one third had low serum free testosterone concentrations at base line; the rest had normal concentrations. Men with other secondary causes of osteoporosis were excluded. All the men received calcium and vitamin D supplements. The main outcome measures were the percent changes in lumbar-spine, hip, and total-body bone mineral density.
The men who received alendronate had a mean (+/-SE) increase in bone mineral density of 7.1+/-0.3 percent at the lumbar spine, 2.5+/-0.4 percent at the femoral neck, and 2.0+/-0.2 percent for the total body (P<0.001 for all comparisons with base line). In contrast, men who received placebo had an increase in lumbar-spine bone mineral density of 1.8+/-0.5 percent (P<0.001 for the comparison with base line) and no significant changes in femoral-neck or total-body bone mineral density. The increase in bone mineral density in the alendronate group was greater than that in the placebo group at all measurement sites (P<0.001). The incidence of vertebral fractures was lower in the alendronate group than in the placebo group (0.8 percent vs. 7.1 percent, P=0.02). Men in the placebo group had a 2.4-mm decrease in height, as compared with a decrease of 0.6 mm in the alendronate group (P=0.02). Alendronate was generally well tolerated.
In men with osteoporosis, alendronate significantly increases spine, hip, and total-body bone mineral density and helps prevent vertebral fractures and decreases in height.
尽管骨质疏松症与残疾、死亡及医疗费用增加相关，但男性骨质疏松症作为一个研究课题相对受到忽视。目前尚无针对男性的大型对照治疗试验。
在一项为期两年的双盲试验中，我们研究了每日服用10毫克阿仑膦酸钠或安慰剂对241名年龄在31至87岁（平均63岁）的骨质疏松男性骨矿物质密度的影响。约三分之一的男性基线血清游离睾酮浓度较低；其余男性浓度正常。排除其他继发性骨质疏松病因的男性。所有男性均补充钙和维生素D。主要观察指标为腰椎、髋部和全身骨矿物质密度的百分比变化。
接受阿仑膦酸钠治疗的男性，腰椎骨矿物质密度平均（±标准误）增加7.1±0.3%，股骨颈增加2.5±0.4%，全身增加2.0±0.2%（与基线相比，所有比较P<0.001）。相比之下，接受安慰剂的男性腰椎骨矿物质密度增加1.8±0.5%（与基线相比P<0.001），股骨颈和全身骨矿物质密度无显著变化。阿仑膦酸钠组在所有测量部位的骨矿物质密度增加均大于安慰剂组（P<0.001）。阿仑膦酸钠组椎体骨折发生率低于安慰剂组（0.8%对7.1%，P = 0.02）。安慰剂组男性身高下降2.4毫米，而阿仑膦酸钠组下降0.6毫米（P = 0.02）。阿仑膦酸钠总体耐受性良好。
在患有骨质疏松症的男性中，阿仑膦酸钠可显著提高脊柱、髋部和全身的骨矿物质密度，并有助于预防椎体骨折和身高降低。
