Prolia® (denosumab) is a treatment for osteoporosis that was first approved by the FDA in 2010 for use in women with osteoporosis who are high risk for fracture.
How Prolia Works
Prolia decreases bone turnover by a different mechanism of action than the other FDA-approved medicines for osteoporosis. The discovery of a signaling pathway for production and activity osteoclasts, the bone breakdown cells, led to the targeting of this pathway for development of Prolia. The molecular mechanism in osteoclast development and activity is named RANK/ RANKL/OPG signaling. Basically Prolia prevents bone loss by blocking the interaction of RANK and RANKL. Blocking this interaction decreases the production, activity, and lifespan of osteoclasts.
Prolia is a Shot
Prolia is given by injection under the skin twice a year in your doctor’s office.
Effectiveness
Prolia is effective in decreasing risk of spine, nonspine, and hip fractures. After three years of use in the pivotal fracture trial of 7800 postmenopausal women, Prolia reduced spine fractures identified by x-ray by 68%, nonspine fractures by 20%, and hip fractures by 41%.
Safety
Possible side effects include back pain, pain in arms or legs, muscle pain, high cholesterol, and bladder infection. Of note, these were the most common reported complaints in both the treatment with Prolia group and placebo.
Other possible serious side effects included skin problems, serious infections, low blood calcium levels, jaw bone problems called osteonecrosis of the jaw, and unusual fractures of the thigh bone called atypical femur fractures.
A “Medication Guide” outlines these risks, which you should discuss with your doctor. In addition, each time you receive your injection in your doctor’s office (every 6 months), you will have the opportunity to participate in gathering of information about safety by answering questions about occurrence of pre-specified side effects.
Should You Consider Prolia?
Prolia may be a good choice for you if you are a postmenopausal woman who has already had a fracture and therefore you are risk for another fracture. Also if you have not responded to other medicines or are stopping your osteoporosis medicine but are still are high-risk for fracture. Also if you are receiving breast cancer therapy that includes a five-year course of medicines like aromatase inhibitors (Armidex, Aromasin, or Femara) that accelerate bone loss, Prolia prevents bone loss and improves bone density.
Prolia approved for use in men with osteoporosis and men with localized prostate cancer receiving treatment that causes bone loss.
Note, if your breast cancer or prostate cancer has spread to the bone, a higher dose of denosumab branded as Xgeva® is given every 4 weeks to prevent additional bone-related complications.
Other Resources: