Shimon Ilan, Eshed Varda, Doolman Ram, Sela Ben-Ami, Karasik Avraham, Vered Iris
Institute of Endocrinology, Chaim Sheba Medical Center, 52621, Tel-Hashomer, Israel.
Osteoporos Int. 2005 Dec;16(12):1591-6. doi: 10.1007/s00198-005-1879-3. Epub 2005 Mar 15.
Male hypogonadism is associated with low bone mineral density (BMD) and an increased risk of fractures. Testosterone replacement therapy improves BMD in young hypogonadal men. This effect is milder in older patients, who are at greater risk for fractures. We studied the effects of alendronate or placebo on BMD in 22 osteoporotic men, 29-69 years of age (mean, 50.2+/-11.2 years) with long-standing hypogonadism, receiving standard testosterone replacement treatment. Alendronate 10 mg daily (n=11) increased lumbar-spine BMD by 6.0 and 8.4% at 6 and 12 months, respectively, compared with -0.5% at 6 months and +3.3% at 12 months in the placebo group (n=11; P<0.005). Alendronate also increased mean femoral-neck BMD by 1.9% after 1 year, compared to a 1.4% decrease with placebo (P<0.005), and increased the total body bone mineral content by 4.4%, compared to a 0.6% decrease with placebo (P=0.07). After 6 months alendronate suppressed urinary deoxypyridinoline by 50% (P<0.005), compared to a 24% decrease in the placebo group. Both the alendronate and placebo groups continued with alendronate 70 mg once weekly for the following 2 years. Lumbar-spine BMD during this open-label study phase did not change significantly in the group originally treated with alendronate, but continued to increase in the placebo-alendronate group by 5.4, 6.5, and 6.2% after 18 (6 months of alendronate), 24 and 36 months, respectively (P<0.05). Femoral-neck BMD continued to increase in both groups receiving active therapy; in the alendronate-alendronate group by 3.7, 2.7, and 5.2% after 18, 24, and 36 months, respectively (P=0.01), and in the placebo-alendronate group by 0.7 and 1.9% at 24 (first 12 months of alendronate) and 36 months, respectively (P<0.05). Our results support the long-term administration of alendronate along with testosterone replacement to men with hypogonadism-induced osteoporosis.
男性性腺功能减退与低骨矿物质密度（BMD）及骨折风险增加相关。睾酮替代疗法可改善年轻性腺功能减退男性的BMD。在骨折风险更高的老年患者中，这种效果较轻微。我们研究了阿仑膦酸钠或安慰剂对22例年龄在29 - 69岁（平均50.2±11.2岁）、患有长期性腺功能减退且接受标准睾酮替代治疗的骨质疏松男性患者BMD的影响。每日服用10 mg阿仑膦酸钠的患者（n = 11），在6个月和12个月时腰椎BMD分别增加了6.0%和8.4%，而安慰剂组（n = 11）在6个月时降低了0.5%，12个月时增加了3.3%（P < 0.005）。1年后，阿仑膦酸钠使股骨颈平均BMD增加了1.9%，而安慰剂组降低了1.4%（P < 0.005）；阿仑膦酸钠使全身骨矿物质含量增加了4.4%，安慰剂组降低了0.6%（P = 0.07）。6个月后，阿仑膦酸钠使尿脱氧吡啶啉降低了50%（P < 0.005），而安慰剂组降低了24%。在接下来的2年中，阿仑膦酸钠组和安慰剂组均继续每周服用一次70 mg阿仑膦酸钠。在这个开放标签研究阶段，最初接受阿仑膦酸钠治疗的组腰椎BMD没有显著变化，但在安慰剂 - 阿仑膦酸钠组中，在18个月（阿仑膦酸钠治疗6个月后）、24个月和36个月时分别继续增加了5.4%、6.5%和6.2%（P < 0.05）。接受积极治疗的两组股骨颈BMD均持续增加；阿仑膦酸钠 - 阿仑膦酸钠组在18个月、24个月和36个月时分别增加了3.7%、2.7%和5.2%（P = 0.01），安慰剂 - 阿仑膦酸钠组在24个月（阿仑膦酸钠治疗的前12个月）和36个月时分别增加了0.7%和1.9%（P < 0.05）。我们的结果支持对性腺功能减退所致骨质疏松的男性患者长期联合使用阿仑膦酸钠和睾酮替代疗法。
