Groundbreaking Osteoporosis Drug Derailed – at Least Temporarily

PJ Hamel Health Guide
  • 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.

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    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.

    Another twist to the story is mounting evidence that Prolia works better than bisphosphonates in reducing the risk of fractures in breast and prostate cancer patients undergoing hormone therapy.

  • Cancer patients taking certain drugs to reduce the negative effect of hormones – aromatase inhibitors (AI) for women with breast cancer; androgen deprivation therapy (ADT) for men with prostate cancer – often develop bone loss as a result.

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    Two research studies reported last June, at the 2009 annual meeting of ASCO (American Society of Clinical Oncology), demonstrated that men taking denosumab (Prolia) vs. a placebo were 62% less likely to develop vertebral fractures, and showed added protection against non-vertebral fractures, as well. And that women and men taking denosumab to deal with low bone density due to ADT or AIs showed significantly higher bone density in the spine, hip, and wrist, compared to patients treated with a placebo.

    The FDA has recommended further clinical trials, to address long-term side effects, and demonstrate that Prolia doesn’t fuel tumor growth.

    Better to be safe than sorry… but I’m sure hoping that the clinical trials happen soon. I’m one of those cancer patients battling bone density loss with Actonel. And a twice-yearly injection of Prolia, with no side effects, sounds a whole lot better than the weekly “gastric distress” offered by Actonel.

Published On: November 08, 2009