Denosumab, A New Medication for Osteoporosis
Injectable Medicine Helps Reverse Bone Loss After Menopause
Oct 2, 2009
According to the National Osteoporosis Foundation, approximately ten million Americans have osteoporosis while another 34 million have experienced bone loss, increasing the risk of fracture. Currently available drugs for osteoporosis fall into two different categories based on how they work. Bisphosphonate medications like Fosamax, Actonel, Boniva and Reclast work to block breakdown of bone, while Forteo helps with building bone.
How Denosumab Works for Bone Loss
Denosumab is a new medication that works differently than other osteoporosis treatments. It blocks a factor in bone development known as RANK ligand. This RANK ligand stimulates production and activity of other cells that increase bone breakdown. By blocking RANK, denosumab may increase bone density and strength. Denosumab may also help to prevent bone tumor growth in cancers like breast and prostate which can spread to the bone. RANK is also important in the immune system. It works in the development of immune cells. Denosumab may have possible applications in treatment for autoimmune conditions like rheumatoid arthritis.
Amgen is Developing Denosumab for Use in Osteoporosis
The biotech company Amgen is bringing denosumab to the market. It will likely be approved for several indications:
- treatment of osteoporosis after menopause
- prevention of osteoporosis after menopause
- treatment and prevention of osteoporosis after hormone treatment for breast cancer
- treatment and prevention of osteoporosis after hormone treatment for prostate cancer
The currently expected brand name will be Prolia.
Studies Using Denosumab in Postmenopausal Osteoporosis
One study in 332 postmenopausal women showed a 6.5% increase in bone density in the spine after treatment with denosumab for two years. Bone density of the hip increased also, but only by about 3.4%.
Additional studies show that denosumab is equally effective as weekly Fosamax in preventing fractures in postmenopausal women. Patients treated for breast cancer showed an increase in bone density after one year of treatment with denosumab, while prostate cancer patients had improvement after two years of treatment.
Denosumab Dosing for Treatment of Osteoporosis
Denosumab is an injectable medication. Patients will receive injections under the skin every 6 months. These injections will need to be given in a health care facility or provider's office.
Side Effects of Denosumab
The most commonly reported problems while taking denosumab include:
- rash
- infection
- headache
- constipation
- sore throat
- joint pain
Questions on Denosumab Medication for Osteoporosis
Long-term use data is not available for denosumab and won't be until the medication actually comes to market. Approval is expected in fall of 2009. Osteoporosis patients interested in denosumab should contact their health care provider with any further questions.
Sources
Bone et al. Effects of Denosumab on Bone Mineral Density and Bone Turnover in Postmenopausal Women J Clin Endocrinol Metab 2008;93:2149-57.
Background Document for Meeting of Healthcare Advisory Committee for Reproductive Health Drugs (Aug 13, 2009).
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