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New Osteoporosis Drugs in the Works

Biologic Osteoporosis Drugs Denosumab and Odanacatib Show Promise in Clinical Trials

Denosumab's Clinical Trial continued...

Denosumab has finished its phase lll clinical trials, the last set of trials needed before submitting a drug to the FDA for approval.

In those trials, postmenopausal women with low bone mineral density either got a shot of denosumab every six months or took alendronate (the active ingredient in Fosamax) every week.

A year later, bone mineral density in the lumbar spine and in the hip had improved more for the denosumab group than for the alendronate group.

Bukata notes that because biologic drugs affect the immune system, researchers keep a close eye on infection rates for biologic drugs, but infections weren't more common with denosumab in the trial.

Cancer risk is another thing that researchers would check on, but tumors weren't more common with denosumab than with alendronate, according to a news release from Amgen, the drug company which makes denosumab.

It's also important that denosumab mainly affects the skeleton and not other body systems, says Bukata, who hasn't seen any worrisome data for denosumab.

"I and others fully expect denosumab up in front of the FDA soon," says Bukata, predicting that denosumab will get FDA approval. "Their data has been good, there have been very solid studies, very open reporting all along the way."

Bukata likes the fact that denosumab is given by injection twice a year, and that those injections don't have to be given by a doctor. That should help with compliance, notes Bukata.

Odanacatib's Trial

Odanacatib takes a different biologic tactic. It targets an enzyme called cathepsin K, in order to reduce osteoclast activity.

Odanacatib isn't as far along in the development process as denosumab; odanacatib's phase lll trial is just getting under way. But two-year results from odanacatib's phase llb trial show promise.

"That data definitely made me pay much more attention this drug," says Bukata.

In the trial, postmenopausal women with osteoporosis took an odanacatib pill or a placebo once a week. Patients don't have to take odanacatib with a meal and they don't have to stand or sit after taking it, notes Ron Rogers, a spokesperson for Merck, the drug company that makes odanacatib.

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