Groundbreaking Osteoporosis Drug Derailed – at Least Temporarily

For those of us dealing with bone loss, news of a new treatment sparks a certain degree of personal interest: “Hey, maybe it’ll work better than what I’m taking now – tell me more!”

Fact is, there aren’t a whole lot of treatments for osteoporosis out there. There’s drugs… and then, there’s drugs.

Think about it: cancer patients have surgery to remove the tumor; chemo and radiation to take care of any errant cells; then long-term drug therapy to keep cancer at bay.

But osteoporosis? You have your choice between Fosamax and Boniva and Actonel. Oh, and maybe Forteo or Reclast. Beyond that, it’s exercise, diet, vitamins, and hope for the best.

Personally, I take Actonel. I find the once-a-week, “sit up straight and don’t drink anything for an hour” regimen kind of a pain – I’m one of those gals who likes to get up at 5 a.m. and go to the gym with a water bottle, not worrying about what time I can take my first sip.

Also, I could do without the Actonel-induced bouts of nausea and “digestive distress.” And is Actonel working for me? Who knows? Guess I’ll find out in a year or so.

Still, it’s not bad… But pharmaceutical manufacturer Amgen’s new drug, Prolia (denosumab), sounds better.

Unlike the vast majority of osteoporosis drugs, Prolia is NOT a bisphosphonate, which means it doesn’t come with the weird dosing restrictions, nor the gastrointestinal issues. Instead, it’s a new type of treatment, called a “biologic” – a drug made from biological processes, the way vaccines are made.

Like bisphosphonates, Prolia focuses on osteoclasts, cells that break down your bones, causing them to “shed” and lose density. But it does it a different way: by targeting a protein called RANK ligand, which controls the activity of osteoclasts. Prolia effectively causes RANK ligand to tell osteoclasts to stop working; thus your bones stop shedding. Researchers feel it’s a more targeted, less “invasive” way to slow bone growth than that offered by bisphosophonates.

Prolia has successfully gone through a total of six different phase III trials involving over 11,000 patients. In early August, an advisory panel to the FDA recommended that it should be approved for the treatment of osteoporosis in postmenopausal women.

But 3 weeks ago, the FDA went against its own panel’s recommendation, sending Amgen back to the drawing board. FDA officials “asked for more information about the design of Amgen’s risk-management plan,” according to a Bloomberg news report from Oct. 19. Amgen is also being asked to provide further information about Prolia’s use in osteoporosis prevention (rather than treatment) in postmenopausal women.

The FDA’s surprising failure to recommend Prolia means the drug may be delayed another 10 months. Which doesn’t seem like very long… unless you’re battling the sometimes VERY uncomfortable side effects associated with bisphosphonates.