promising drug for bone loss

[Guest guest]

Imagine going to a doctor's office once a year for treatment of a chronic

medical condition. No daily pills. No weekly therapies. Just 30 minutes or

so in a clinic.

It could happen. A new osteoporosis drug called zoledronic

acid has been shown to increase bone mineral density in rates similar to

those achieved with medications taken daily or weekly. Now, a large study

involving thousands of people will establish whether annual intravenous

infusions can help prevent spine and hip fractures in people with

osteoporosis. If eventually approved by the Food and Drug Administration,

zoledronic acid would be one of several ways to treat bone loss. But doctors

are exuberant at the prospect of having a long-lasting therapy in their bag

of tricks.

" It will change the way we treat osteoporosis, " said Dr.

Stuart Silverman, a clinical professor of medicine at UCLA and an

investigator in the Phase 3 clinical trial. " Right now, osteoporosis is

underrecognized, underdiagnosed, and undertreated. "

About 55 percent of people over age 50 have low bone mass,

and 10 million Americans have osteoporosis, according to the National

Osteoporosis Foundation. The disease can lead to an increased risk of

fractures and, sometimes, death for elderly people who break a hip.

Many elderly people with fractures are treated for the

injury but don't receive medications or therapy to prevent additional

fractures, Silverman said. That might change if zoledronic acid infusions

could be given as part of a comprehensive treatment for a fracture. About 20

percent of people with one fracture will have another break.

With zoledronic acid on hand, he said: " We would fix [the

fracture] and then give them their osteoporosis treatment before they leave

the hospital. We'd know they were protected for the next year. "

A once-a-year treatment would also benefit people who

can't tolerate daily osteoporosis medications such as Fosamax and Actonel.

Like zoledronic acid, these drugs are from a class of compounds called

bisphosphonates. And though they're powerful protectors of bone, they're

hard on the stomach, says Silverman.

Furthermore, many people have trouble sticking to a

daily-pill regimen; studies have shown that the average person stops taking

long-term medications after six months, he said.

Zoledronic acid infusions appear to be well-tolerated. The

major side effects are low-grade fever, musculoskeletal pain, or nausea

following the infusion. Zoledronic acid, made by Novartis Pharmaceuticals

Corp., is not a new drug. It's already being used, under the name Zometa, to

treat complications of cancer that have spread to the bone.

" Bisphosphonates are a class of compounds that are soaps, "

said Silverman, medical director of the Osteoporosis Medical Center, a

non-profit research center in Los Angeles. " They bind directly to the bone.

They create a slippery surface and make it very difficult for the cells that

remove bone to attach. "

Researchers don't yet understand how a single, yearly dose

of bisphosphonates can protect bone as well as a daily therapy. But a

greater understanding of the drug is expected to emerge during the

three-year study launched in November.

The study will test zoledronic acid in several groups:

post-menopausal women with osteoporosis, people with recent hip fractures,

and people with Paget's disease, the most serious degenerative bone

disorder. Researchers will enroll 11,000 patients in 400 centers around the

world in one of the largest drug-evaluation programs undertaken in the area

of metabolic bone diseases.

If the medication proved successful at preventing

fractures, it would probably be used in conjunction with other osteoporosis

treatments, such as the newly approved medication Forteo, which can help

build new bone.

" There are a lot of exciting things happening with

osteoporosis, " said Silverman.

" It's not a disorder of aging. It's treatable. "

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Those interested in learning more about the clinical

trial, may call (877)-YHORIZON or log on to horizon.novartis.com.

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