Prolia® (generic name: denosumab) is a recently developed drug prescribed for a wide range of conditions of the skeletal bones, including osteoporosis, bone loss induced by radical treatments for cancer, cases where cancers have metastasized to bones, and giant cell tumors of bones.
Denosumab is a human monoclonal antibody. Monoclonal antibody therapy has two main influences in the body:
- It inhibits the formation of osteoclasts (the cells involved in the breakdown and resorption of bones), which will allow for an increased bone mineral density (BMD), thereby reducing the risk of fracture.
- It helps the body’s immune system to target tumor cells or abnormal cells in the body that are otherwise recognized as body cells, but are leading to health-threatening disabilities.
Denosumab (Prolia®) as a Treatment for Osteoporosis
Osteoporosis frequently occurs in women after menopause. As a result of the loss of bone density, they are at a higher risk of bone fractures. It is also prescribed for men with osteoporosis, which usually develops due to prostate surgery.
Prolia® is prescribed to treat osteoporosis in men and women at high risk of bone fractures who will be taking a daily dosage of 7.5 mg or more of glucocorticoids (prednisone) and are expected to remain on this course of treatment for at least six months.
Prolia® as a Treatment for Bone Density loss caused by Cancer Therapies
Tumor cells that proliferate rapidly and body cells that are dying cause physiological problems, but they generally are not targeted by the immune system since they are the patient’s own cells. Several treatments for such cancers carry the risk of decreasing bone density, which can lead to osteoporosis. In such cases, Prolia® may be prescribed to counter this.
Prolia® is prescribed to treat bone loss in men who have been receiving androgen deprivation therapy for nonmetastatic prostate cancer (cancer that has not spread to other parts of the body) and in women who are receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer.
Other uses of Prolia® include for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, and in the treatment of giant cell tumors when surgical resection could lead to severe morbidity.
What is the current incidence of Osteoporosis?
According to the US Department of Health and Human Services, around ten million people aged fifty and older have osteoporosis. Approximately 80% of these are post-menopausal women, but about 2 million are men. A further 43 million more people have been diagnosed with low bone mass, putting them at increased risk for the development of osteoporosis down the road.
What are the effects of Osteoporosis?
Due to lower bone density, fractures can occur more frequently in the vertebrae (spine), carpals, hips, pelvis and upper arms. Such fractures can result in other disabilities and even lead to early mortality. Many patients require long-term hospitalization and nursing care, which can severely impact the patient’s family. The social impact of treatment for osteoporotic fractures is predicted to be more than $25 billion by 2025.