- The Washington Times - Thursday, February 28, 2002


A single intravenous dose of medicine a year rather than a pill a day may be enough to prevent osteoporosis, the bone-thinning condition that leads to fractures and hunched backs, especially in women past menopause.

The startling finding comes out of a study of a drug called zoledronic acid, which is approved for use in cancer patients to stop calcium from leaching from the bones.

It will be about five years before doctors know whether the drug does prevent fractures, because the study in today's New England Journal of Medicine is only a one-year look at the medicine's effect on bone itself. The manufacturer, which paid for the research, already had begun the much larger and longer studies.

But doctors who treat osteoporosis a disease that weakens the bones of more than 10 million Americans are excited by the preliminary results.

Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation, says the thought of a once-a-year treatment is mind-boggling.

"It's potentially a huge change in treatment and, I think, prevention of osteoporosis," said Dr. Ian R. Reid of the University of Auckland, New Zealand, who led the study. "I think it almost comes into the category of a flu shot, rather than taking pills every day and having side effects."

Over the course of a year, 351 women in New Zealand, Austria, Switzerland, Belgium, France, Italy, Germany, Austria, Sweden and Canada were given four five-minute intravenous infusions three months apart. One-sixth of the women received a placebo in all four; the others had at least one IV containing zoledronic acid.

All five drug treatment schedules had about the same results, and all were better than the placebo. The drug was found to slow the rate of bone loss and increase bone density, and the effects persisted for at least a year after treatment, long after the medication had disappeared from the blood.

Bone density was 4.3 percent to 5.1 percent higher in the spine and 3.1 percent to 3.5 percent higher in the hip than it was for patients on placebo.

The drug, sold by Novartis Pharmaceuticals Corp. as Zometa, is in a class called bisphosphonates. Two other drugs in this class are used as one-a-day pills to treat osteoporosis; one also is available as a once-a-week pill.

However, the pills must be taken sitting or standing straight up, before eating, and the patient has to stay upright for 30 minutes without eating or drinking. Side effects include abdominal pain, nausea, heartburn and irritation of the esophagus. Research has shown that such patients often skip their pills or do not take them according to instructions.

The IV treatment has fewer side effects, Dr. Cosman said.

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