New Osteoporosis Drug Coming?
2 Positive Studies Published on Experimental Drug Denosumab; FDA Panel Review This Week
Denosumab's Side Effects
Denosumab didn't show an increased risk of infection or cancer -- risks seen with other types of biologic drugs -- in either trial.
Denosumab also wasn't linked to osteonecrosis of the jaw (sometimes called "jawbone death"), which has been reported with other osteoporosis drugs called bisphosphonates.
But eczema and severe cases of a skin infection called cellulitis were more common in women taking denosumab in Cummings' study. The reason for that isn't clear.
Denosumab's safety profile "appeared excellent" in the prostate cancer study, Smith says, adding that the study was the first large study of fracture prevention in men.
"Previously, there had been no large studies to address that problem in men with prostate cancer, and frankly, not in men in any setting," Smith says.
Both denosumab studies were sponsored by the drug's maker, Amgen. Smith and Cummings disclose working as consultants for Amgen, and several researchers on both studies are Amgen employees.
Denosumab "seems at least as efficacious as the currently approved alternatives," states an editorial published with the studies.
But editorialist Sundeep Khosla, MD, of the Mayo Clinic's medical school in Rochester, Minn., notes that there haven't been any head-to-head trials comparing denosumab to other osteoporosis drugs for fracture prevention, that the drug's longer-term safety isn't known yet, and that cost could be an issue if denosumab is pricey. Khosla notes no conflicts of interest.
Cummings says there are plans to follow the patients in his study for at least 10 years. He also hopes that patients will be more compliant about taking denosumab than other osteoporosis drugs.
"It's as effective as any other treatment and can be given twice a year as a simple injection, like a flu shot" and can be given by a nurse or primary care doctor, Cummings says.
Susan Bukata, MD, an osteoporosis specialist and associate professor of orthopaedics at New York's University of Rochester Medical Center, says denosumab would be "another option" for people who can't or won't take other osteoporosis drugs, such as people with kidney failure or gastrointestinal issues.
"There's definitely a place for this drug," Bukata says. "I think still, the gold standard is we start on the pills, we start on the generics. But this is certainly a good second-line choice and for some patients ... this may be my first-line choice."
Bukata wasn't involved in the denosumab trials. She discloses that she expects to soon work on a clinical trial of another Amgen drug.