Decade of denosumab data shows consistent safety profile

Bone health

26 Oct 2015

Denosumab treatment for up to 10 years is associated with a persistent reduction of bone turnover, continued increases in bone mineral density and a low incidence of fractures in postmenopausal women with osteoporosis, according to new data from the FREEDOM Extension trial.

Dr Henry G Bone III, MD, from the Michigan Bone and Mineral Clinic, in Detroit, presented data for the 7-year extension of the original 3-year trial at the American Society for Bone and Mineral Research held in Seattle earlier this month.  

Results showed that women treated for 10 years with denosumab achieved an average cumulative 10-year gain in BMD of 21.7 percent at the lumbar spine and 9.2 percent at the total hip, compared to baseline in the Phase 3 fracture study.

Overall rates of AEs and serious AEs were consistent with data reported previously in the extension study and yearly rates of new vertebral and nonvertebral fractures remained low.

During the seven years of the extension, 13 oral events were confirmed as osteonecrosis of the jaw (ONJ) and two events were confirmed as atypical femoral fracture by independent adjudication committees. No atypical femoral fractures or ONJ cases were reported in the original three-year core study.

The findings are from an extension of the Phase 3 FREEDOM fracture study of 7,808 women with postmenopausal osteoporosis who were randomly assigned to receive denosumab (Prolia) (60 mg) or placebo subcutaneously every six months for three years, after which they could choose to enter a seven-year extension study.

The study received funding from Amgen.

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