According to the results of a Phase III clinical trial, treatment with denosumab significantly reduces the risk of vertebral and hip fractures among postmenopausal women with osteoporosis. These results were presented at the 2008 meeting of the American Society for Bone and Mineral Research (ASBMR).
Osteoporosis is a disease that affects the bones, making them fragile, weak, and prone to fractures. Fractures related to osteoporosis typically occur in the hip, spine, and wrist. In the United States, an estimated 10 million individuals already have osteoporosis, and an additional 34 million have low bone mass and are at increased risk of developing osteoporosis.
Denosumab is an investigational drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Denosumab is being evaluated for the management of bone loss among patients with a variety of conditions, including cancer patients with treatment-related bone loss and postmenopausal women with osteoporosis.
To evaluate denosumab among postmenopausal women with osteoporosis, researchers conducted an international Phase III clinical trial known as the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) Trial. The study enrolled 7,808 women between the ages of 60 to 90, all of whom had osteoporosis.
Study participants were assigned to receive either denosumab or a placebo every six months for three years. All study participants also received calcium and vitamin D.
- Women treated with denosumab were 68% less likely to develop a vertebral fracture and 40% less likely to develop a hip fracture than women in the placebo group.
These results provide additional evidence regarding the efficacy of denosumab in reducing the risk of bone fractures among women with osteoporosis.
 National Institute of Arthritis and Musculoskeletal and Skin Diseases. Osteoporosis Overview. Available at: http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/default.asp (Accessed September 16, 2008).
 Cummings SR, McClung MR, Christiansen C et al. A phase III study of the effects of denosumab on vertebral, nonvertebral, and hip fracture in women with osteoporosis: Results from the FREEDOM Trial. Presented at the 2008 meeting of the American Society for Bone and Mineral Research (ASBMR), September 12-16, 2008, Montréal, Quebéc, Canada. Abstract 1286.