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March 13 2002
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Annual Dose of Drug May Help Fight Osteoporosis

 

An annual infusion of a drug now used to treat cancer patients can boost bone density in healthy postmenopausal women just as well as medications that must be taken by mouth every day.

The drug, Zometa (zoledronic acid), was first approved to treat excessive amounts of calcium in the blood in cancer patients, and February 19th the US Food and Drug Administration (FDA) extended this approval to treatment of tumors that have spread to bone.

Zometa belongs to a class of drugs called bisphosphonates, which are used orally to treat osteoporosis. These drugs have drawbacks, the researchers note, including gastrointestinal intolerance and poor absorption by the gastrointestinal tract.

To investigate whether Zometa might be an effective osteoporosis treatment -- and sidestep the problems seen with oral drugs- researchers tested the drug in over 350 postmenopausal women with low bone mineral density.

According to the report, researchers observed increases in bone mineral density among all Zometa-treated patients for one year which were 5% higher than increases seen in the placebo-treated patients.

The increases in bone mineral density among Zometa-treated patients were comparable to increases experienced with daily doses of three other drugs: Actonel, Fosamax and Aredia.

The rates of adverse events were similar among all Zometa-treated patients. Among those treated with Zometa, the most common side effects were musculoskeletal pain, nausea and fever, most of which were reported as mild.

The maker of Zometa, Swiss drug giant Novartis, helped fund the study.

Osteoporosis has been regarded as requiring daily therapy, and maintaining compliance with daily regimens for a predominantly asymptomatic condition has been a major problem. Administration of treatment at intervals of 6 to 12 months or more is likely to be much more acceptable to patients.

The New England Journal of Medicine February 28, 2002;346:653-661



Dr. MercolaDr. Mercola's Comments:

Osteoporosis is a real problem as it affects more than 25 million Americans -- mostly women past menopause. Approximately 1.2 million bone fractures each year in the US are related to osteoporosis.

Well, wouldn't life be all nice if we could all line up for our annual osteoporosis shot?

Sure it would, but the fact of the matter is the only benefit of this very expensive drug is Novartis, the company that funded the NEJM study above.

Any idea what this once a year wonder drug costs?

Try Google under Zometa costs and the second hit will tell you that in August of last year it was $856. No telling what it will be if it is approved. But let's round it off to an even $1000.

If the drug truly worked it would probably be justified. After all it is hard to beat compliance on a once a year drug and there is a significant morbidity in osteoporosis.

But the fact of the matter is that this once a year drug doesn't work. It is just another dangerous biphosphonate drug, just like Fosamax.

Optimum bone density is a dynamic balance between bone removal, or resorption, by cells called osteoclasts which replace old bone by releasing acids and enzymes to remove minerals and collagen. Once the osteoclasts have done their job, protein-secreting cells called osteoblasts deposit new tissue .

Approximately 20% of bone tissue is replaced annually by this process on a cyclical basis throughout the skeleton. The entire remodeling process occurs over approximately 4 to 8 months, with a range of 3 months to 2 years.

Bisphosphonates are a family of non-hormonal drugs used to prevent and treat osteoporosis. There are four bisphosphonates currently in clinical use, alendronate (Fosamax), etidronate (Didronel) and risedronate (Actonel), and pamidronate (Aredia).

The problem is however that biphosphonates poison the osteoclasts, the cells that are responsible for removing damaged bone.

So the bone truly does become denser. I have no doubt that the study is accurate and the bones are 5% denser. But the real issue is what about long-term? Denser bones do not necessarily translate to stronger bones.

For early prevention or inhibition of postmenopausal and age-related bone loss, nutritional interventions should be the first choice as they are the least toxic and least expensive option. While other nutrients are important for maintaining high bone densities, there is increasing evidence indicates a significant role for vitamin K in bone metabolism and osteoporosis.

Osteocalcin is a protein specifically produced by the osteoblasts, and is utilized within the bone as an integral part of the process of its formation. However, osteocalcin requires to be carboxylated before it can be effective in bone formation.

Vitamin K functions as a cofactor for the enzyme that catalyzes the carboxylation of osteocalcin.

Vitamin K was recently compared to a first-generation biphosphonate drug called Didronel in 72 osteoporotic women for two years and there was no difference was found in the bone fracture rates between vitamin K and the biphophonate drug.

I hope to post a definitive review of how to optimize bone density, but I can assure you that It is a far more complex issue than just adding calcium. The problem is complex, but vitamin K is clearly an important part of the puzzle as it helps "glue" the calcium directly into the bone matrix.

Vitamin K is absolutely essential to build strong bones. Green leafy vegetables supply almost half of the vitamin K for the majority of Americans, but most foods considered rich in vitamin K have shown to have less vitamin K than previously thought.

For this reason, I now offer the most potent disease-fighting form of this vitamin available -- vitamin K2 -- in supplemental form, if you would like to add some to your dietary intake.

I recently completed a review of this topic and submitted it to British Medical Journal and will post it once they have made a decision on publication.

However, therapeutic levels of vitamin D are also very important.

Related Articles:

Fosamax May Damage Liver

Fosamax Increases Ulcer Risk Especially if Taken With Anti-Inflammatories

Does Fosamax (Aldrenoate) Prevent Bone Loss? Two New Studies Say It Does, I Say Beware!

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