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    Thursday, May 03, 2007

    Take Once Yearly: Is the new solution for osteoporosis a once a year intravenous infusion?

    Millions of women could be protected against life-threatening hip fractures by a once-a-year treatment with a new drug.

    ....The new treatment cuts the risk of such fractures by more than 40 per cent.

    ....The new drug, zoledronic acid (Aclasta) has been tested on almost 8,000 women in a trial that included patients from Aberdeen, Sheffield, Liverpool and Glasgow.

    They were given annual infusions of either Aclasta or a placebo, and followed for three years. The results, published in the New England Journal of Medicine, showed a 70 per cent reduction in fractures of the vertebrae of the spine, and a 41 per cent reduction in hip fractures. Breaks elsewhere in the body, such as the wrist, were reduced by 25 per cent.

    Sounds impressive. It did seem to make a significant impact on vertebral fractures:

    Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group...

    Not so dramatic for the hip:

    ...and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group.

    What about side effects? We've heard that intravenous bisphosphanates can cause osteonecrosis of the jaw. This study says it wasn't a problem:

    There were no spontaneous reports of osteonecrosis of the jaw. From a search of the trial database of adverse events, which was followed by expert adjudication, two cases of potential osteonecrosis of the jaw were identified (one in the placebo group and one in the zoledronic-acid group). In both patients, delayed healing followed surgical manipulation, and both cases subsequently resolved with antibiotic therapy and d├ębridement. A similar search for and review of osteonecrosis of the hip or knee revealed seven cases (three in the placebo group and four in the zoledronic-acid group). No adverse effect on fracture healing was observed, with three cases of nonunion (one in the placebo group and two in the zoledronic-acid group).

    But wait. Zoledronic acid is Zometa, which has been implicated in bone death, at least in cancer patients. Might want to sit this one out for a while and see how the side effects shake out.

    posted by Sydney on 5/03/2007 07:32:00 AM 0 comments


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