Study finds osteoporosis drug safe in long-term trial

Results from a three-year clinical trial in women between age 60 and 90 shows adverse events did not increase after the initial period of treatment with denosumab.
By Amy Wallace   |   March 17, 2017 at 12:07 PM

March 17 (UPI) -- Researchers have determined the osteoporosis drug denosumab is safe and effective at treating osteoporosis and preventing bone fractures.

The study examined the short- and long-term safety effects of denosumab, a monoclonal antibody that works against RANKL to decrease osteoclast formation, function and survival.

Women between age 60 and 90 who were treated with the drug in a three-year clinical trial had reported adverse events, but the study showed no increase in adverse events including back pain, pain in extremities, musculoskeletal pain, hypercholesterolemia and cystitis, after further treatment over an additional three-year time period.

"All of this is consistent with an excellent safety and tolerability profile for denosumab treatment for osteoporosis," Dr. Nelson Watts, of Mercy Health in Cincinnati, said in a press release.

Researchers noted that in older women on long-term treatment, most if not all adverse events could be described as "life events" that would have happened regardless of the clinical trial.

The study showed 60 mg denosumab given every six months reduced vertebral fractures by 68 percent, hip fractures by 40 percent and nonvertebral fractures by 20 percent.

Denosumab also was found to increase bone mineral density and reduce bone turnover markers in postmenopausal women with osteoporosis when compared to a placebo.

The study was published in the Journal of Bone and Mineral Research.

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