唑来膦酸可预防骨质疏松男性椎骨骨折

《新英格兰医学杂志》10月31日在线发表的一项临床试验显示，每年注射1次唑来膦酸可使骨质疏松的男性新发形态学椎骨骨折的风险显著降低67%(N. Engl. J. Med. 2012 Oct. 31 [doi:10.1056/NEJMoa1204061])。

比利时鲁汶大学医院Steven Boonen博士介绍，这项为期2年的双盲研究从欧洲、南美、非洲和澳大利亚招募男性骨质疏松患者，随机分组，553例患者每年1次注射5 mg唑来膦酸，另外574例患者注射安慰剂。结果显示，仅有活性药物组获得了显著而持久的腰椎、全髋、股骨颈骨密度提升，并且在具有不同血清睾酮水平的患者中均有上述效果。

唑来膦酸组仅有1.6%的男性发生了新的椎体骨折，而安慰剂组为4.9%，两组风险的绝对差异为3.3%，相对差异为67%。唑来膦酸对男性椎体骨折风险的降低程度，与既往在女性骨质疏松患者中观察到的结果相似，提示该药的抗骨折效应独立于患者性别。

Boonen博士及其同事认为，既然已经找到了男性骨质疏松的有效治疗手段，就可以开始筛查和预防男性骨折了。

这项研究由诺华制药资助，后者是唑来膦酸的生产商。作者报告称与多家药企存在利益关系。

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By: MARY ANN MOON, Clinical Endocrinology News Digital Network

Annual infusions of zoledronic acid significantly decreased the risk of new morphometric vertebral fractures by 67% in men who had osteoporosis, according to an industry-sponsored clinical trial published online Oct. 31 in the New England Journal of Medicine.

In a 2-year double-blind study conducted in Europe, South America, Africa, and Australia, 553 men with osteoporosis were randomly assigned to receive once-yearly infusions of 5 mg zoledronic acid and 574 were assigned to receive placebo infusions. Only the active drug produced significant and sustained increases in bone mineral density at the lumbar spine, total hip, and femoral neck, and it did so across all levels of serum testosterone, said Dr. Steven Boonen of the Center for Metabolic Bone diseases and the division of geriatric medicine, University Hospitals Leuven (Belgium), and his associates.

Only 1.6% of the men receiving zoledronic acid developed new vertebral fractures, compared with 4.9% of those receiving placebo, a difference that corresponded with an absolute risk reduction of 3.3 percentage points and a relative risk reduction of 67%. This reduction is similar to that seen in women with osteoporosis who receive zoledronic acid, suggesting that the antifracture effect of the drug is independent of patient sex, the investigators said (N. Engl. J. Med. 2012 Oct. 31 [doi:10.1056/NEJMoa1204061]).

Now that an effective treatment has been identified for men with osteoporosis, public health efforts to detect the disease and prevent fractures in the male population, which have been inadequate to date, can be stepped up, Dr. Boonen and his colleagues added.

This study was funded by Novartis Pharma, maker of zoledronic acid. The authors reported numerous ties to industry sources.