Zoledronic Acid Okayed for Two-Year Treatment of Osteoporosis

Zoledronic Acid Okayed for Two-Year Treatment of Osteoporosis
By Kristina Fiore, Staff Writer, MedPage Today
Published: June 01, 2009

WASHINGTON, June 1 -- The FDA has approved zoledronic acid (Reclast) to prevent postmenopausal osteoporosis for two years with a single injection.

The drug is currently approved as a once-yearly infusion for treating the disease.

The approval comes after a two-year randomized controlled trial of 581 postmenopausal women, which found that the drug significantly increased lumbar spine bone mineral density compared with placebo -- by 6.3% in women who were in early menopause and by 5.4% in those in later stages.

"The dosing of [zoledronic acid] for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years instead of daily, weekly, or monthly, Mone Zaidi, M.D., Ph.D., of Mount Sinai School of Medicine in New York, said in a statement.

According to the FDA, the drug should not be given to patients with low blood calcium, kidney problems, or an allergy to zoledronic acid. It also should not be given to women who are pregnant or nursing.

Common side effects include flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting, and diarrhea. Jaw problems have also been reported with use of the drug, the FDA said.

Zoledronic acid is also approved to treat Paget's disease.

By hummingbird36
Posted June 20, 2009 at 9:23 pm
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Hi all, I have just had an infusion of Reclast. I was fearful since I had heard the side effects can be bad. I have had no side effects at all and feel fine. I chose Reclast since non of the other osteo drugs have helped me except the 2 years I was on Forteo. I have -3.2 of the spine. I felt it was worth the risk. Hummingbird36

By Loods
Posted June 21, 2009 at 8:39 am
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I think you summed it up Hummingbird36, when you said "it was worth the risk" because that is what Osteoporosis drugs seem to be about - risk.

For some the drugs seem to work well, but for those that have bad side effects the risks are not worth it, leaving us with greater problems than when we start.

I have never understood why there are so many different drugs to combat one problem. It's like "well that one doesn't work very well, let's just try and manufacture another." No wonder the market is awash with poor treatments!

By Char42
Posted June 21, 2009 at 10:33 am
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Hey Hummingbird, lucky you I am very scared of Reclast or any of the Bisphosphonates, had all the oral ones. It was awful and after 2 plus years I still feel some jawbone soreness. Very risky.
I live on Hummingbird Lane and have never seen a hummingbird in this development, alas just a name.

By letshope
Posted June 21, 2009 at 10:39 am
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i have a vertebrae of -3.6...with 5 fractures in a just a few months (including the T-7& 8), i'd had no successes with any treatments, drugs, nutrition or exercise.

the side effects were bad the first two days and after a week or two...i haven't felt anything. i have until september before i have another dexa, but i was willing to take the "risk" since nothing seemed to be working and i'm a very active 45 year old.

actually, the HRT i started a couple months ago is giving me some severe emotional side effects and i may have to discontinue that. i can't keep loosing it, crying and going postal on everything that upsets me even a little. i'd rather live without all that estrogen coursing through my veins.

By letshope
Posted June 21, 2009 at 10:44 am
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1 vs 2 years,
i also have to ask, it was already approved for once a year...what's the difference here with two years? that's not explained....

By PikaB
Posted June 21, 2009 at 11:13 am
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letshope: My understanding is that the current, once yearly infusion is for treatment of osteoporosis. The two-year infusion is to prevent osteoporosis (in other words, for treatment of "osteopenia").

By SusanRae
Posted June 22, 2009 at 10:37 pm
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Dear Let's Hope:

I am currently a few chapters into Dr. Lee's book, "What Your Doctor May Not Tell You About Menopause." He talks about the use of progesterone in very small doses for pre- and postmenapausal women. You might want to check it out. I was going to try to explain what I think he's saying, but don't want to get it wrong. It sounds like sometimes people have a lack of progesterone which creates an imbalance with estrogen. Woody at Sequoia has mentioned this book several times and could probably explain it better than I. Or you could get the book. I found it at my library--maybe you could find it at yours, too. Try e-bay.

Susan

By BoneLady
Posted June 24, 2009 at 11:40 am
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Looks like Novartis Pharmaceuticals Corp. found themselves a gold mine. Not only are Reclast injections VERY EXPENSIVE, but now the company has FDA approval to give it not only once a year to women with osteoporosis but also every two years to women with osteopenia. That should cover most all women over 50 years of age and many who are years younger!

Here is the company's rationale:
"Although low bone mass is less severe in people with osteopenia than those with osteoporosis, they are still at increased risk of fractures. In fact, research shows that approximately half of women who experience a fragility fracture, or a broken bone due to a fall from standing height or less, have osteopenia, highlighting the importance of treating and preventing further bone loss."

I can certainly understand treating a woman with osteopenia who has already had a fragility fracture and maybe even one without fractures but with a very strong family background of osteoporosis. But, otherwise, giving zoledronic acid injections or any other bisphosphonate to healthy women with BMD in the osteopenia range is criminal, and I would question the motivation of any doctor who recommends it.

Welcome to Inspire!

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