March 8, 2009

Fareston® Decreases Spinal Fractures in Men with Prostate Cancer


Fareston® Decreases Spinal Fractures in Men with Prostate Cancer

Among prostate cancer patients receiving androgen deprivation therapy (ADT), treatment with Fareston® (toremifene citrate) reduces the risk of new spinal fractures. These results were presented at the 2008 annual meeting of the American Association for Cancer Research.

Prostate cancer is the most common cancer among American men. Men with advanced or metastatic disease are often treated with ADT. Adverse effects of ADT include impotence, hot flashes, cardiovascular problems, abnormal lipid profiles, and osteoporosis. Finding ways to counteract these adverse effects- while still preserving the effectiveness of ADT against prostate cancer-would improve the overall health and well-being of men treated with ADT.

Fareston is a selective estrogen receptor modulator (SERM) that is approved for treatment of advanced breast cancer. Fareston also decreases osteoporosis and reduces fracture risk in postmenopausal women, and has been evaluated in prostate cancer prevention trials in men with early prostatic dysplasia.

The current study involved 1,389 men with prostate cancer who were assigned to receive either Fareston or placebo for two years. All study participants were currently receiving ADT and had an elevated risk of fracture.

  • 1.5% of men in the Fareston group had new vertebral fractures compared with 3.5% of men in the placebo group.
  • Fareston increased bone mineral density at the spine, hip, and femoral neck.
  • Fareston increased high-density lipoprotein (”good” cholesterol).
  • Fareston decreased hot flashes and breast pain.
  • Fareston increased the risk of blood clots.

These results suggest that Fareston may reduce fracture risk and other adverse treatment effects among prostate cancer patients receiving ADT.

Men receiving ADT for prostate cancer may wish to talk with their physician about the risks and benefits of participating in a clinical trial further evaluating this or other novel therapeutic approaches. Two sources of information about ongoing clinical trials are the National Cancer Institute ( and eCancerTrials (

Reference: Smith M, Morton RA, Wallace H, et al. A phase III randomized controlled trial of toremifene to prevent fractures and other adverse effects of androgen therapy in men with prostate cancer. Proceedings of the 99th Annual Meeting of the American Association for Cancer Research;2008;abstract LB-241.

Related News: Exercise Reverses Bone Loss Caused by Androgen Deprivation for Prostate Cancer Patients (11/7/2007)

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