by Dr. C.H. Weaver M.D. updated 10/2020
Denosumab increases bone mineral density (BMD) and reduces the risk of fractures in women with postmenopausal osteoporosis and individuals with cancer treatment related bone loss. Denosumab is marketed as Prolia® for the treatment of postmenopausal women with osteoporosis at high risk for fracture and as Xgeva for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Denosumab works by targeting a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). By decreasing osteoclast activity denosumab reduces bone loss due to cancer treatment, and postmenopausal osteoporosis resulting in increased BMD and reduced fractures.
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.(1)
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.(2) Half were treated with denosumab twice a year for three years and the other half received placebo. 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 here (Accessed September 16, 2008).
- Cummings SR, San Martin J, McClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. New EnglandJournal of Medicine. Early online publication August 11, 2009.