Novartis drug aids bones in Paget’s disease

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A dose of the Novartis drug Zometa (zoledronic acid) halted bone deterioration and abnormal bone growth for at least one year in about 95 percent of patients with Paget’s disease, an international study released on Wednesday showed.

“I’m a little reluctant to say ‘cure,’” said Paul Miller, a leader of the study that was conducted at 76 medical centers in 10 countries.

But Zometa produced a “higher response, faster response and a longer duration of remission” in tests against daily treatments of Procter & Gamble Pharmaceutical’s Actonel (risedronate), Miller told Reuters.

Paget’s disease appears when the body breaks down its bones faster than normal and new bone doesn’t replace it properly.

The condition is found in about 2 percent of people over 60. As many as 7 percent of the elderly in western Europe have it as well. In some cases, it can be painful and increase the risk of fracture.

The study, published in The New England Journal of Medicine, found that one dose of zoledronic acid led to six months of improvement in 96 percent of 176 people tested compared with 74 percent of 171 patients who received risedronate.

While the effects of risedronate, when it worked, wore off in one quarter of the volunteers after one year, that happened in less than 1 percent of the zoledronic recipients.

The drug can cause flu-like symptoms, such as mild fever and muscle aches, but they typically disappear after four days, said the researchers, led by Ian Reed of the University of Auckland in New Zealand.

Zoledronic acid is under review by the U.S. Food and Drug Administration as a treatment for Paget’s disease. It has been approved for that use in Canada and 27 European countries. The drug is already used to treat high calcium levels caused by some types of cancer.

Miller cautioned that the single intravenous dose of zoledronic acid will not necessarily replace risedronate.

Many patients, especially those who aren’t in pain, find it easy to take the risedronate tablets once a day for two months, and many get long-lasting improvement as well.

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