Prolia has been available for postmenopausal women for 2 years. It is the only Antiresorptive appropriate for persons with both reflux disease (GERD) and decreased renal function (mild kidney failure). But it was not FDA approved for men. Now it is approved, but only for a few men.
Men with Prostate Cancer taking medications to eliminate Testosterone (hormonal ablation) and without metastases (cancer spread to bone and other tissues) are now approved for Prolia. Prolia can delay the spread of cancer to bone, sometimes for years. All other men must wait for studies demonstrating that Prolia works on osteoporosis the same in men as in women.
So far, all osteoporosis medications have had comparable effects in men as in women. However, the FDA requires separate studies to prove efffectiveness in each sex. Naturally the first studies are done on postmenopausal women since they have the greatest likelihood of osteoporosis and high fracture risk.
Ironically, Denosumab (the active ingredient in Prolia) had already been approved for use in men. The cancer drug Xgeva is Denosumab given in higher doses and more often. It is approved in men with prostate and other cancers who DO have metastases to bone. Xgeva can be very effective in slowing, and sometimes reversing, the growth of metastases in bone and other tissues when combined with other treatments. That’s a winner.
I look forward to some day being able to use Prolia on men without cancer, but with high fracture risk for other reasons. The more options we have, the better we can tailor treatment to each individual person.
Jay Ginther, MD