Dr. Goldstein comments on NY Times article on new Osteoporosis drug

In yesterday‘s New York Times, a teaser on the front page was entitled “Treatment for brittle bones”. The article itself was entitled “Osteoporosis drug deploys genetic tool to build bone”. On Tuesday the FDA approved a new drug known as Evenity (generic is romosozumab-aqqg). The article talks significantly about the fact that this is the first drug that restores bone without breaking it down. Understand that bone is a dynamic organ. It is constantly being laid down and taken away until the day you die. Estrogen is a potent inhibitor of taking bone away. This is why when women at menopause stop making estrogen they lose bone rapidly. Most of the commonly employed medications to prevent and treat osteoporosis are such “anti-resorptives” (they inhibit the taking away of bone like estrogen did yielding a net positive balance). There are some injectables that are anabolic bone drugs (like Forteo or Tymlos) that actually build bone but do not inhibit some of it’s taking away. Previously these have been reserved for the most severe cases and are limited to 18 months of use because of some bone cancers observed in rodents. This new drug, Evenity, actually uses genetically engineered blocking antibodies to restore bone without breaking it down.

  To some of you who may have read the article, this may sound like a wonderful breakthrough and something you might in fact be interested in. Understand, this was a clinical trial of close to 8,000 women. All of them had osteoporosis and at least one pre-existing osteoporotic fracture of the vertebral column. In other words all these women were extremely high risk. Bone health is increasingly one of the most important issues for my patients. As longevity has increased dramatically over the last generation or two, so many women are living into their early 90s. Suffering a hip fracture will result in 25% of women never living independently again and 20 to 30% will be dead within one year. My patients should be as concerned about their bone health as any other aspect of their lives as they pursue “healthy aging.”

  My take-home point, however, is that this drug is an excellent “arrow in the quiver” of clinicians who take care of women with severe osteoporosis and previous fracture. It is a monthly injectable. It is not for patients with average bone loss or early osteoporosis. It should be reserved for the most severely affected patients. It is not without potentially serious side effects. The most serious ones, as pointed out in the article, were a statistically significant increase in heart attacks, strokes, and even sudden death among women who used this medication. That is why, obviously, it should only be reserved for severely affected women with osteoporosis and pre-existing fracture. 

  As usual, I hope you find this commentary on articles in the news Media helpful.