Treatment with denosumab (Prolia®) was associated with greater reductions in fracture risk over time in postmenopausal women compared with oral alendronate, according to new data from a real-world study presented at the 2023 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO).
The retrospective, observational study evaluated US Medicare beneficiary data from January 1, 2012 to December 31, 2018. The study included 478,651 postmenopausal women 66 years of age and older with no history of prior osteoporosis treatment who received either denosumab (n=89,115) or oral alendronate (n=389,536).
Findings showed denosumab reduced the relative risk (RR) of fracture vs oral alendronate, with a 36% reduced risk of hip fractures (RR, 0.64; 95% CI, 0.39-0.90), a 43% reduced risk of nonvertebral fractures, including fractures to the hip, humerus, pelvis, radius/ulna and other femur (RR, 0.57; 95% CI, 0.42-0.71), a 30% reduced risk of hospitalized vertebral fractures, (RR, 0.70; 95% CI, 0.40-1.01; not statistically significant), a 39% reduced risk of major osteoporotic; nonvertebral and hospitalized vertebral fractures (RR, 0.61; 95% CI, 0.48-0.74), and a 50% reduced risk of non-hip, nonvertebral fractures (RR, 0.50; 95% CI, 0.35-0.64).
The analysis also demonstrated that longer duration of treatment with denosumab led to a greater reduction in risk of major osteoporotic (MOP) fracture: 9% at year 1 (RR, 0.91; 95% CI, 0.85-0.97), 12% at year 2 (RR, 0.88; 95% CI, 0.83-0.93), 18% at year 3 (RR, 0.82; 95% CI, 0.77-0.87), 31% at year 5 (RR, 0.69; 95% CI, 0.62-0.76), and 39% overall (RR, 0.61; 95% CI, 0.48-0.74).
“These findings from nearly half a million patients provide evidence that Prolia is associated with greater fracture risk reduction than with alendronate,” said lead study investigator Jeff Curtis, MD, MS, MPH, professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. “This comparative effectiveness research employs rigorous methodology that provides important insights that are relevant to the care of women living with osteoporosis.”
New data from Amgen’s Prolia® (denosumab) demonstrates significant reduction in osteoporotic fracture risk compared to alendronate. News release. Amgen. Accessed May 8, 2023. https://www.multivu.com/players/English/9094351-new-data-amgen-prolia-denosumab/.