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Randomized Controlled Trial of Annual Zoledronic Acid to Prevent Gonadotropin-Releasing Hormone Agonist–Induced Bone Loss in Men With Prostate Cancer

M. Dror Michaelson, Donald S. Kaufman, Hang Lee, Francis J. McGovern, Philip W. Kantoff, Mary Anne Fallon, Joel S. Finkelstein, Matthew R. Smith

From the Division of Hematology and Oncology and Endocrine Unit, Department of Medicine, Department of Urology, and Biostatistics Center, Massachusetts General Hospital; and the Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, MA

Address reprint requests to Matthew R. Smith, MD, Massachusetts General Hospital, Department of Hematology/ Oncology, 100 Blossom St, Cox 640, Boston, MA 02114; e-mail: smith.matthew{at}mgh.harvard.edu

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.

Supported by the W. Bradford Ingalls Foundation and research awards from the Prostate Cancer Foundation and Novartis Oncology.

The study sponsors played no role in the study design; in collection, analysis, and interpretation of data; or in writing of this report.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Related Editorial

• Annual Zoledronic Acid: Is Less More?
  Celestia S. Higano
  JCO 2007 25: 1026 [Full Text]

Related Correspondence

• Patient Quality of Life Safeguarding: The Primary Aim in Nonmetastatic Prostate Cancer Patients
  Tommaso Cai and Riccardo Bartoletti
  JCO 2007 25: 3385 [Full Text]

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