The Use of Zoledronic Acid in Men Receiving Androgen Deprivation Therapy for Prostate Cancer With Severe Osteopenia or Osteoporosis
The Use of Zoledronic Acid in Men Receiving Androgen Deprivation Therapy for Prostate Cancer With Severe Osteopenia or Osteoporosis
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DOI：
10.1016/j.urology.2009.11.083
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发表时间：
2010-05-01
期刊：
影响因子：
2.1
通讯作者：
Reda, Domenic J.
中科院分区：
文献类型：
--
作者：
Campbell, Steven C.;Bhoopalam, Nirmala;Reda, Domenic J.
目的：研究唑来膦酸对接受雄激素剥夺治疗（ADT）的既存骨质疏松症患者的影响，这些患者是骨折风险最高的患者。唑来膦酸是一种有效的双膦酸盐，可预防开始ADT的非转移性（M0）前列腺癌（CaP）患者的骨质疏松症。唑来膦酸对既存骨质疏松症患者ADT的影响，谁是骨折的最高风险，还没有得到充分的study.METHODS我们招募了28例患者与M0钙磷对ADT严重骨量减少或骨质疏松症（基线骨矿物质密度（BMD）T评分< -2.0）在这个开放标签，单臂试验，以评估唑来膦酸对BMD的影响。所有患者还接受了补充钙和维生素D，并建议改变生活方式。患者接受唑来膦酸（4 mg）静脉注射，每3个月一次，共4次治疗。在入组时、6个月和12个月时通过双能X线骨密度仪扫描测量BMD。主要终点是腰椎BMD的百分比变化。结果这是一个高风险的患者人群，主要是老年白人（平均年龄73岁），前吸烟者和中度饮酒者。ADT的平均持续时间为2.4年。在9例患者的单个部位和19例（68%）的多个部位观察到既存骨质减少或骨质疏松症。唑来膦酸治疗12个月后，腰椎BMD增加4.17%（P <0.0001），双侧髋关节和右侧股骨颈BMD显著增加（P <0.05）。7名患者（25%）的BMD改善至非骨质疏松范围（T评分> -2.0）。唑来膦酸输注耐受性良好，没有实质性的肾toxics.CONCLUSIONS唑来膦酸改善男性的BMD与M0钙磷ADT严重骨量减少或骨质疏松症（T评分< 2.0）。这一新的发现确定了一个高风险的患者群体，可能受益于双膦酸盐治疗。泌尿学75：1138-1143，2010年。(C)2010年爱思唯尔公司
OBJECTIVES To study the effect of zoledronic acid on patients with pre-existing osteoporosis on androgen deprivation therapy (ADT), who are at highest risk for fracture. Zoledronic acid is a potent bisphosphonate that can prevent osteoporosis in patients with nonmetastatic (M0), prostate cancer (CaP) who are initiating ADT. The effect of zoledronic acid on patients with pre-existing osteoporosis on ADT, who are highest risk for fracture, has not been adequately studied.METHODS We enrolled 28 patients with M0 CaP on ADT with severe osteopenia or osteoporosis (baseline bone-mineral density (BMD) T score < -2.0) in this open-label, single-arm trial to assess the effect of zoledronic acid on BMD. All patients also received supplemental calcium and vitamin D, and were counseled about lifestyle modifications. Patients received zoledronic acid (4 mg) intravenously every 3 months for 4 treatments. BMD was measured by dual energy X-ray absorptiometry scan at enrollment, 6 and 12 months. Primary endpoint was percent change in lumbar spine BMD.RESULTS This was a high-risk patient population-primarily older Caucasians (mean age, 73 years), former smokers, and moderate users of alcohol. Mean duration of ADT was 2.4 years. Pre-existing osteopenia or osteoporosis was observed in a single site in 9 patients and multiple sites in 19 (68%). After 12 months of zoledronic acid, lumbar spine BMD increased 4.17% (P < .0001), and BMD increased significantly (P < .05) in both hips and the right femoral neck. Seven patients (25%) experienced improved BMD into the nonosteoporotic range (T score > -2.0). Zoledronic acid infusion was well tolerated and without substantial renal toxicity.CONCLUSIONS Zoledronic acid improves BMD in men with M0 CaP on ADT with severe osteopenia or osteoporosis (T scores < 2.0). This novel finding identifies a high-risk patient population that can potentially benefit from bisphosphonate therapy. UROLOGY 75: 1138-1143, 2010. (C) 2010 Elsevier Inc.