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

J Clin Oncol. 2007 Mar 20;25(9):1038-42. doi: 10.1200/JCO.2006.07.3361.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Androgen Antagonists / adverse effects*
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Bone Density / drug effects
  • Bone Density Conservation Agents / administration & dosage*
  • Bone Density Conservation Agents / therapeutic use
  • Bone Remodeling / drug effects
  • Boston
  • Diphosphonates / administration & dosage*
  • Diphosphonates / therapeutic use
  • Drug Administration Schedule
  • Fractures, Bone / chemically induced
  • Fractures, Bone / prevention & control
  • Gonadotropin-Releasing Hormone / agonists*
  • Humans
  • Imidazoles / administration & dosage*
  • Imidazoles / therapeutic use
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Osteoporosis / chemically induced
  • Osteoporosis / physiopathology
  • Osteoporosis / prevention & control*
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / pathology
  • Time Factors
  • Treatment Outcome
  • Zoledronic Acid

Substances

  • Androgen Antagonists
  • Antineoplastic Agents, Hormonal
  • Bone Density Conservation Agents
  • Diphosphonates
  • Imidazoles
  • Gonadotropin-Releasing Hormone
  • Zoledronic Acid