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Bone Density Drug Approved for Prostate and Breast Cancer Patients

Posted Oct 04 2011 10:28pm

Bone Density Drug Approved for Prostate and Breast Cancer Patients

The Food and Drug Administration (FDA) has approved the use of denosumab (Prolia, Xgeva) to increase bone mass in two groups of patients at high risk for fractures: men receiving androgen deprivation therapy for nonmetastatic prostate cancer and women receiving an aromatase inhibitor as post-surgical or adjuvant therapy for breast cancer.
Denosumab is a monoclonal antibody that binds to and interferes with RANKL, a protein involved in the formation, function, and survival of the cells responsible for bone resorption .

The approvals were based on results from two international randomized double-blind placebo-controlled trials. 

The Hormone Ablation Bone Loss (HALT) trial included nearly 1,500 men with nonmetastatic prostate cancer who were undergoing androgen deprivation therapy. Denosumab was also tested in a 2-year trial that enrolled 252 postmenopausal women with hormone receptor-positive breast cancer who had been treated with an adjuvant aromatase inhibitor.

Both trials showed that one 60 mg injection of denosumab every 6 months increased bone mineral density compared with placebo. In men with prostate cancer, denosumab also reduced the incidence of vertebral fractures and increased bone density in other areas, including the neck and hip. Joint and back pain were the most frequently reported adverse reactions reported by patients treated with denosumab. 

The FDA previously approved denosumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, as well as for the prevention of skeletal-related events in patients with bone metastases from solid tumors. 


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