Edward Hines Jr VA Hospital, Hines, Illinois, USA.
Urology. 2010 May;75(5):1138-43. doi: 10.1016/j.urology.2009.11.083. Epub 2010 Mar 19.
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.
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.
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.
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.
研究唑来膦酸对接受雄激素剥夺治疗（ADT）的、伴有预先存在的骨质疏松症且骨折风险最高的非转移性（M0）前列腺癌（CaP）患者的影响。唑来膦酸是一种有效的双膦酸盐，可预防接受 ADT 的非转移性（M0）前列腺癌（CaP）且伴骨质疏松症患者的骨质疏松症。唑来膦酸对伴有预先存在的骨质疏松症且骨折风险最高的接受 ADT 的患者的影响尚未得到充分研究。
我们在这项开放标签、单臂试验中纳入了 28 例患有 M0 CaP 且正在接受 ADT 治疗、伴有严重骨质减少或骨质疏松症（基线骨矿物质密度（BMD）T 评分< -2.0）的患者，以评估唑来膦酸对 BMD 的影响。所有患者还接受了钙和维生素 D 的补充，并接受了生活方式改变的咨询。患者接受 4 次静脉注射唑来膦酸（4 mg），每 3 个月 1 次。在入组时、第 6 个月和第 12 个月，通过双能 X 射线吸收法测量 BMD。主要终点是腰椎 BMD 的百分比变化。
这是一个高危患者群体，主要是年龄较大的白种人（平均年龄 73 岁）、曾经吸烟和中度饮酒者。ADT 的平均持续时间为 2.4 年。9 例患者在单个部位存在预先存在的骨质减少或骨质疏松症，19 例患者（68%）在多个部位存在。唑来膦酸治疗 12 个月后，腰椎 BMD 增加了 4.17%（P <.0001），并且在双侧髋关节和右侧股骨颈的 BMD 均显著增加（P <.05）。7 例患者（25%）的 BMD 改善至非骨质疏松范围（T 评分> -2.0）。唑来膦酸输注耐受良好，无明显肾毒性。
唑来膦酸可改善接受 ADT 的伴有严重骨质减少或骨质疏松症（T 评分< 2.0）的 M0 CaP 患者的 BMD。这一新发现确定了一个高危患者群体，他们可能受益于双膦酸盐治疗。
