Prolia, the New Darling in the Treatment of Osteoporosis

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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When certain medications come along that may transform the way we treat common conditions, like osteoporosis, you should know about it. So, what is this new injection for osteoporosis?

Prolia (denosumab) is an injection given every 6 months for the treatment and prevention of osteoporosis. Here is what you need to know about the injection that may change the management of osteoporosis:

What medications do we have now? Bisphosphonate medications are the current first line treatment of osteoporosis and include the well known once a week alendronate (Fosamax) and once a month ibandronate (Boniva). These medications work well but do carry the known, and very rare, complication of jaw osteonecrosis (“dead jaw bone”) and can irritate the esophagus. They are taken on an empty stomach with a full glass of water and you can’t eat or lie down for an hour after taking them. They work, and are now quite cheap as they come in generic forms.

How does Prolia work? Differently from the bisphosphonates. Prolia is what is called a monoclonal antibody (hint, a medication whose generic name ends in -mab is a monoclonal antibody). Prolia inhibits the activation of osteoclasts which break down bone.

Is it already approved? Yes, Prolia is currently indicated for the treatment of osteoporosis in women with high fracture risk in whom other medications (listed above) have not been effective, or who cannot tolerate those medications.

Does it work better than alendronate and ibandronateWe don’t yet know if Prolia works better to prevent fractures than the older meds but we do know it improves bone density better than alendronate. Stay tuned on this, my bet is the fracture prevention will be better.

How do you use ProliaIt is a subcutaneous (under the skin) injection given every 6 months (60 mg).

It Prolia expensive? Yep. It costs $1,980 for 1 year of therapy though the manufacturer does offer a co-pay program and a patient assistance program.

Is Prolia safe? Three to five year follow up studies have shown that 2% of women can have a drop in calcium (hypocalcemia) and as with bisphosphonates, denosumab has been associated with osteonecrosis of the jaw. Again, exceedingly rare.

Is Prolia well tolerated? Here is why you will need to know about this medication. Prolia is well tolerated and patients report higher satisfaction with Prolia as compared to oral bisphosphonates like Alendronate. So, folks prefer getting a shot every 6 months over taking the pill.

Bottom line. Prolia is an expensive injection for the prevention of osteoporotic hip fractures and other effective, cheaper options exist. Prolia is, however, preferred by patients in studies over the pills and it may work better. Worth it?

Dr O.

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