(HealthDay)—Denosumab does not appear to delay fracture healing or contribute to other complications when used to treat postmenopausal women with osteoporosis, according to research published in the Dec. 5 issue of The Journal of Bone & Joint Surgery.
To examine the impact of denosumab administration on fracture healing, Silvano Adami, M.D., Ph.D., of the University of Verona in Italy, and colleagues conducted a pre-planned analysis of the three-year, placebo-controlled FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every Six Months) study. The study included postmenopausal women (aged 60 to 90 years) with osteoporosis who received either 60 mg of denosumab (3,902 women) or placebo (3,906 women) subcutaneously once every six months for three years.
The researchers identified 386 nonvertebral fractures among 303 denosumab-treated women and 465 fractures among 364 placebo-treated women, of which 199 fractures were treated surgically (79 and 120 in the denosumab and placebo groups, respectively). Seven individuals experienced delayed healing, including one with subsequent nonunion; two of these women were treated with denosumab and five received placebo. None of the women who experienced delayed fracture healing or nonunion had received denosumab within six weeks of the fracture. In 2 percent of the denosumab group and 5 percent of the placebo group there was a complication associated with the fracture or intervention.
"In the thirty-six-month FREEDOM trial, there was no evidence that denosumab treatment delayed healing or contributed to complications related to a nonvertebral fracture or its management," the authors write. "However, since the exact timing of completion of fracture healing could not be determined, it remains theoretically possible that denosumab might delay or speed fracture healing."
The study was funded by Amgen, which developed denosumab. Several authors disclosed financial ties to an entity in the biomedical arena.
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