Zometa® (zoledronic acid) reduces bone loss and promotes bone recovery among prostate cancer patients treated with androgen deprivation therapy, according to results presented at the 2005 annual Chemotherapy Foundation Symposium in New York.

The prostate is a gland of the male reproductive system. It produces some of the fluid that transports sperm during ejaculation. After skin cancer, prostate cancer is the most common form of cancer diagnosed in men. The outlook for men diagnosed with prostate cancer is good; overall survival rates for all stages of prostate cancer have improved dramatically over the past 20 years.

Current treatment options for prostate cancer include watchful waiting, surgery, chemotherapy, radiation, or androgen deprivation therapy (also referred to as hormonal therapy). Androgen deprivation therapy is designed to block testosterone from stimulating the growth of hormone-dependent types of prostate cancer.

Treatment with androgen deprivation therapy can have such adverse effects on bone as reductions in bone mineral density, increased risk of fractures, and osteoporosis.

Studies indicate that treatment with the bisphosphonate drug Zometa slows loss of bone mineral density when given at the start of androgen deprivation therapy, but it’s uncertain whether it remains effective when started after androgen deprivation therapy has already begun.

Researchers from 19 U.S. medical centers recently conducted a randomized clinical trial to evaluate the effect of Zometa on bone loss. They studied 101 men with prostate cancer who had already received up to a year of androgen deprivation therapy. Patients were randomly assigned to receive either Zometa (4 mg IV every 3 months for up to one year) or placebo. Men continued treatment with androgen deprivation therapy during the study and also took calcium and vitamin D supplements. Bone mineral density was measured at baseline (6 months) and 12 months.

Treatment with Zometa was found to have a positive effect on bone mineral density.

Men who had been on androgen deprivation therapy for less than six months before starting Zometa had the following results:

  • Bone mineral density at the hip increased 0.9% for those on Zometa and decreased 3.1% for those on placebo.
  • Bone mineral density at the lumbar spine increased 4.9% for those on Zometa and decreased 2.1% for those on placebo.

Men who had been on androgen deprivation therapy for 6-12 months before starting Zometa had these results:

  • Bone mineral density at the hip increased 2.4% for those on Zometa and decreased 0.6% for those on placebo.
  • Bone mineral density at the lumbar spine increased 4.0% for those on Zometa and decreased 2.1% for those on placebo.

The most common side effects associated with Zometa were nausea, hot flashes, fatigue, and bone pain.

The researchers concluded that treatment with Zometa not only reduces bone loss associated with androgen deprivation therapy in men with prostate cancer, but also recovers bone. The researchers also stated that Zometa was safe and well tolerated.

Reference: Ryan C, Beer T, Huo D, et al. A randomized, placebo-Controlled, Trial of Zoledronic Acid for Bone Loss Initiated During the First Year of Androgen Deprivation Therapy in Prostate Cancer Patients. Proceedings from the 2005 annual Chemotherapy Foundation Symposium. November 2005. New York, NY. Abstract #58.

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