Randomized controlled trial of annual zoledronic acid to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer

被引:231
作者
Michaelson, M. Dror
Kaufman, Donald S.
Lee, Hang
McGovern, Francis J.
Kantoff, Philip W.
Fallon, Mary Anne
Finkelstein, Joel S.
Smith, Matthew R.
机构
[1] Massachusetts Gen Hosp, Dept Hematol Oncol, Div Hematol & Oncol, Boston, MA 02114 USA
[2] Massachusetts Gen Hosp, Dept Med, Endocrine Unit, Boston, MA 02114 USA
[3] Massachusetts Gen Hosp, Dept Urol, Boston, MA 02114 USA
[4] Massachusetts Gen Hosp, Ctr Biostat, Boston, MA 02114 USA
[5] Dana Farber Canc Inst, Dept Adult Oncol, Boston, MA 02115 USA
关键词
D O I
10.1200/JCO.2006.07.3361
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and increase fracture risk in men with prostate cancer. Annual zoledronic acid increases BMD in postmenopausal women, but its efficacy in hypogonadal men is not known. Patients and Methods In a 12-month study, 40 men with nonmetastatic prostate cancer who were receiving a GnRH agonist and had T scores more than -2.5 were randomly assigned to zoledronic acid (4 mg intravenously on day 1 only) or placebo. BMD of the posteroanterior lumbar spine and proximal femur were measured by dual-energy x-ray absorptiometry. Results Mean (+/- SE) BMD of the posteroanterior lumbar spine decreased by 3.1% +/- 1.0% in men assigned to placebo and increased by 4.0% +/- 1.0% in men assigned to zoledronic acid (P < .001). BMD of the total hip decreased by 1.9% +/- 0.7% in men assigned to placebo and increased by 0.7% +/- 0.5% in men assigned to zoledronic acid (P = .004). Similar between-group differences were observed for the femoral neck and trochanter. Serum N-telopeptide, a marker of osteoclast activity, decreased significantly after zoledronic acid treatment. Conclusion In men receiving a GnRH agonist, a single treatment with zoledronic acid significantly increased BMD and durably suppressed serum N-telopeptide levels for 12 months. Annual zoledronic acid may be a convenient and effective strategy to prevent bone loss in hypogonadal men.
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页码:1038 / 1042
页数:5
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