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New Osteoporosis Drug Under FDA Scrutiny

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A new drug for treating osteoporosis is up for approval by the FDA. An advisory panel of experts has recommended that denosumab, a biotech compound made by Amgen, be approved for treating postmenopausal women with osteoporosis. These are the people who are at greatest risk for fractures. A new study shows that denosumab injected twice a year cut the rate of fractures of the vertebrae from about 7 percent to just over 2 percent, a relative risk reduction of 68 percent.

The panel did not recommend that the drug be used in treating cancer patients whose treatment has weakened their bones, although a study in The New England Journal of Medicine shows that denosumab increased bone mineral density and decreased spinal fractures in men being treated for prostate cancer. The advisory panel is concerned about an increased risk of infection and cancer among patients given denosumab. If the FDA approves the drug, it will become available under the brand name Prolia.

[New England Journal of Medicine, Aug. 20, 2009]

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Actonel (like Fossamax and Boniva) works by stopping bone remodeling. I had to go off of it (on the advice of my primary doc) in order to get a broken collarbone to mend. Strangely, the orthopedic guy treating me didn't know that (so I fired him!).

Actonel gave me deep bone pain. I would be willing to put up with that if I trusted the drug. I became concerned that simply mineralizing somewhat hollow bone would make it even more brittle- read about similar concerns.
I didn't resume taking it. Taking Ca, D and added Magnesium (sidenote: the magnesium made a huge difference for me-I obviously had a deficiency. I take 250mg twice a day)
Any insights would be appreciated about the osteo drugs...

After suffering from a sternum fracture, I am now needing to begin a new bone-building med. I was taking Actonel at the time I fell, resulting in the fracture. Do you have a recommendation?

While there are many times when a prescription for treating bone loss is important, natural solutions are always in order, and can complement and augment the effects of conventional medicine. I recommend having a blood test done to determine if you have a vitamin D deficiency.

Also, several servings of soy foods weekly will help, as scientific evidence supports its benefit for bone health. You can find calcium in cow’s milk, but sometimes cow milk creates problems for humans, so look for other calcium rich foods such as calcium fortified orange juice, broccoli, collards, bok choy, and kale. These can also go a long way in preventing osteoporosis.

Robert Pendergrast, MD

The contents of this comment are for informational purposes only and do not render medical or psychological advice, opinion, diagnosis, or treatment. The information provided through this comment should not be used for diagnosing or treating a health problem or disease. It is not a substitute for professional care. If you have or suspect you may have a medical or psychological problem, you should consult your appropriate health care provider. Never disregard professional medical advice or delay in seeking it because of something you have read on this comment.

Dear Y'all -- it's now 2012 -- doesn't anyone else have info or comments about Prolia ??

I took Fosomax-D for 3 years - it worked fairly well but now after being off it for 3 am at a -2.5 DEXA score in hip --and with the side -effect of non-causal fractures a very real possibility my gyno is recommending Prolia but a commitment to a six-month injection drug and the possible
attendant side-effects has me concerned ...

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