An Injection a Year May Keep Bone Loss at Bay

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"This study provides an alternative route of treatment for a class of medications that has been found to be very helpful in osteoporosis care and may be able to effectively treat men and women who have struggled on oral therapy," added Dr. Susan Bukata, clinical director of the Center for Bone Health at the University of Rochester.

Bukata further emphasized that "this study is really important for men who do not have many choices for therapy."

Just as Effective

The data show and experts agree that yearly infusions of Reclast appear to be at least as effective as currently available osteoporosis treatments in preventing all osteoporotic fractures, not just hip and spine fractures.

Bukata said, "[Reclast's efficacy] certainly matches the standard set by the oral bisphosphonates and shows true fracture protection equivalent to these drugs."

She also touts the benefits of a treatment that provides yearlong protection.

"[Patients] are much more likely to comply when the dosing is tied into a [yearly] doctor's visit," she said, "especially if they have to do nothing in between visits except take their calcium and vitamin D."

Mahon, who was in the study, couldn't agree more.

"I think it's marvelous," said Mahon, who does not know yet if she was in the treatment [Reclast] or nontreatment [placebo] group. "The fact that you can take something and it can last a year is a great incentive to go get it done."

Experts are especially enthusiastic about its potential to treat those who, like Mahon, have had trouble with or cannot take oral bisphosphonates.

Possible Heart Side Effect

However, the study also found serious cases of atrial fibrillation to be more prevalent among the Reclast treatment group. Fifty patients in the treatment group experienced this potentially dangerous heart condition, compared with 20 patients in the placebo group.

This was an unexpected finding that Dr. Felicia Cosman, osteoporosis specialist at the Helen Hayes Hospital, said has never been observed in any of the previous clinical trials of this particular drug.

Experts say this particular side effect may be common to all bisphosphonates, but it's too early to tell.

Still, most experts such as Dr. C. Conrad Johnston Jr., distinguished professor of medicine at the Indiana University School of Medicine, say these drugs, including Reclast, are quite safe with relatively few side effects.

And there is evidence that Reclast may allow patients to avoid a rare but serious side effect associated with the use of bisphosphonates. This condition, called osteonecrosis of the jaw, can cause the jaw bone to die away, leading to pain and dysfunction.

For now, however, patients may have to wait. Dr. Juliet Compston, professor of bone medicine at the University of Cambridge in the United Kingdom and author of the accompanying editorial to the study, said, "I don't think it should change clinical practice [at this time]."

But, since Reclast would only need to be given once a year, experts are encouraged that many more people will get it and stick with it if it is approved.

"It is an important addition to our armamentarium to fight osteoporosis," Johnston said.

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