Analysis of initial trial data suggest that toremifene improves lipid levels and bone mineral density in men receiving androgen deprivation therapy for advanced prostate cancer, according to a presentation at the American Society of Clinical Oncology’s Prostate Cancer Symposium.

Androgen deprivation therapy has been shown to decrease bone mineral density and increase fracture risk. It is also known to increase cholesterol and triglyceride levels, potentially contributing to the recently reported link between androgen deprivation therapy and cardiovascular disease.

Toremifene is a selective estrogen receptor modulator, a type of hormonal therapy commonly used to treat women with advanced breast cancer. In these patients, it improves bone mineral density and lipid profiles. Toremifene also appears to lower the risk of prostate cancer in men with a form of prostate precancer.

“In previous studies, other agents?including bisphosphonates?have also been associated with significant improvements in bone mineral density in men receiving androgen deprivation therapy for prostate cancer,” said Matthew Smith, MD, PhD, Associate Professor of Medicine at Massachusetts General Hospital Cancer Center and the study’s lead author. “However, these results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve lipid levels, addressing another significant side effect of the standard treatment for this disease.”

The ongoing phase III trial includes 1,392 men age 50 years or older receiving androgen deprivation therapy for advanced prostate cancer at several centers in the United States and Mexico who were randomized to toremifene (80 mg/day) or placebo for two years.

In one planned interim analysis, bone mineral density after one year was measured in 200 men. Toremifene significantly increased bone mineral density in the lumbar spine by 1.6 percent, in the hip by 0.7 percent, and in the neck of the femur by 0.2 percent. In contrast, men in the placebo group experienced decreases in bone mineral density at these sites of 0.7 percent, 1.3 percent, and 1.3 percent, respectively.

In a second planned interim analysis, lipid levels were analyzed in 197 men after one year. Toremifene decreased total cholesterol by 7.1 percent, low-density lipoprotein cholesterol by 9.0 percent, and triglycerides by 20.1 percent, while increasing high-density lipoprotein cholesterol levels by 5.4 percent compared with placebo.