Novartis drug aids bones in Paget’s disease
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.
Paget’s disease is a metabolic bone disease that involves bone destruction and regrowth which results in deformity.
Causes, incidence, and risk factors
The cause of Paget’s disease is unknown. There are theories about early viral infection and genetic causes. The disease occurs worldwide, but is more common in Europe, Australia, and New Zealand - where it is seen in up to 5% of the elderly population.
The disease is characterized by excessive breakdown of bone tissue, followed by abnormal bone formation. The new bone is structurally enlarged, but weakened and filled with new blood vessels.
The disease may localize to one or two areas within the skeleton, or become widespread. Frequently, bones of the pelvis, leg, spine, arm, or the collar bone are involved. The effect on the skull may enlarge head size and cause hearing loss, if the cranial nerves are damaged by the bone growth.
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.
Revision date: July 5, 2011
Last revised: by Dave R. Roger, M.D.