Denosumab bests alendronate as first-line therapy for fracture prevention in osteoporosis
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Key takeaways:
- Denosumab as a first-line osteoporosis therapy is linked to lower fracture risks than alendronate among postmenopausal women.
- Risk for fractures among denosumab users decreases more over time.
Postmenopausal women with osteoporosis who use denosumab as a first-line therapy have lowers risk for fractures compared with women who use alendronate, according to an industry press release.
In findings from an observational, retrospective study presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, researchers analyzed data from U.S. Medicare beneficiaries of postmenopausal women with osteoporosis and no history of prior osteoporosis treatment. The data revealed women using denosumab (Prolia, Amgen) had lower risks for multiple types of fractures than women using alendronate, including hip fractures, nonvertebral fractures, major osteoporotic fractures and non-hip and nonvertebral fractures.
“The efficacy of denosumab to reduce fractures was greater than for alendronate for multiple fracture types with a clinically relevant effect size,” Jeffrey R. Curtis, MD, MS, MPH, the Marguerite Jones Harbert – Gene Ball Endowed Professor of Medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham, told Healio. “At least through 5 years, the fracture benefit with denosumab continued to increase with additional years of treatment.”
Curtis and colleagues analyzed data from 478,651 postmenopausal women aged 66 years and older with no history of prior osteoporosis treatment. Data were collected from U.S. Medicare beneficiaries from 2012 to 2018. Women who took denosumab or alendronate as a first-line therapy were included. Participants were followed from drug initiation until the first instance of a fracture outcome, discontinuation or change in therapy, disenrollment from Medicare or death.
Of the cohort, 89,115 women used denosumab as a first-line therapy and 389,536 used alendronate. At the end of the follow-up, the denosumab group had a lower risks for hip fracture (RR = 0.64; 95% CI, 0.39-0.9), nonvertebral fractures (RR = 0.57; 95% CI, 0.42-0.71), major osteoporotic, nonvertebral and hospitalized vertebral fractures (RR = 0.61; 95% CI, 0.48-0.74) and non-hip, nonvertebral fractures (RR = 0.5; 95% CI, 0.35-0.64) than the alendronate group. There was no difference between the two groups in risk for hospitalized vertebral fractures.
Women in the denosumab group had further reductions in risk for major osteoporotic fractures with longer duration of use. Compared with using alendronate, women who used denosumab had reduced risks for major osteoporotic fractures at 1 year (RR = 0.91; 95% CI, 0.85-0.97), 2 years (RR = 0.88; 95% CI, 0.83-0.93), 3 years (RR = 0.82; 95% CI, 0.77-0.87) and 5 years (RR = 0.69; 95% CI, 0.62-0.76).
“It was encouraging to see that the superior gains in bone mineral density observed with denosumab compared to oral bisphosphonates found in past studies appear to translate into demonstrable improvement in superior fracture benefit in this study,” Curtis said.
Curtis said more studies are planned to analyze fracture risks among adults using denosumab compared with those using zoledronic acid and to examine whether risk is reduced among denosumab users who previously used bisphosphonates.
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