New Osteoporosis Drugs in the Works
Biologic Osteoporosis Drugs Denosumab and Odanacatib Show Promise in Clinical Trials
WebMD News Archive
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
"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 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,"
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.