Denosumab gives FREEDOM to heal fractures

Nov 2 2012

By Lynda Williams, Senior medwireNews Reporter

Results from the FREEDOM trial indicate that fracture healing is not impaired in women with osteoporosis who use the antiresorptive therapy denosumab.

Three years of data for 667 women aged 60 to 90 years participating in the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every Six Months) study show no increased risk for incomplete fracture healing between patients randomly assigned to receive denosumab 60 mg at 6-month intervals and those given placebo.

Nonvertebral fractures were reported for 386 patients given the monoclonal antibody RANK ligand inhibitor and for 464 controls, with surgery required for 79 and 120 fractures, respectively.

Incomplete fracture healing 6 months after injury was similar in the two groups, affecting two denosumab-treated and five placebo-treated patients. One control experienced fracture nonunion. Fracture or treatment complications were also comparable, affecting five and 20 patients, respectively.

Of note, none of the patients who sustained a fracture within 6 weeks of denosumab treatment experienced delayed healing or nonunion, report Joseph Lane (Hospital for Special Surgery, New York, USA) and co-authors.

Writing in the US edition of the Journal of Bone and Joint Surgery, the team says there is "no evidence that denosumab treatment delayed healing or contributed to complications related to a nonvertebral fracture or its management.

"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."

Acknowledging that the effects of denosumab are reversed on treatment discontinuation, the researchers conclude: "The practical implication is that a subcutaneous injection of denosumab may be administered at the time of, or soon after, a nonvertebral fracture without concerns about pyrexia or inflammatory signs resulting from its administration.

"Denosumab provides an option to address the need for osteoporosis treatment and reduce the risk of subsequent fractures in patients presenting for care of an osteoporotic fracture."

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