‘Consistent reductions’ in moderate, severe vertebral fractures with romosozumab therapy
Romosozumab is associated with marked reductions in all vertebral fracture grades, and these are sustained after transition to antiresorptive agents, post hoc analyses from the FRAME and ARCH studies show.
Data published in Bone also show the effect of romosozumab-aqqg (Evenity, Amgen), approved in 2019 for women with a history of osteoporotic fracture or multiple risk factors for fracture, was independent of baseline vertebral fracture prevalence or severity.
“Fracture severity has been associated with increased morbidity and mortality; the higher the severity, the greater the morbidity and subsequent fracture risk,” Piet Geusens, MD, PhD, professor emeritus in rheumatology at the University of Maastricht, the Netherlands, and Hasselt University, Belgium, and colleagues wrote in the study background. “Accordingly, an improved understanding of vertebral fracture treatment efficacy, across the spectrum of new and existing vertebral fracture severities, is highly relevant to clinical practice.”
Geusens and colleagues analyzed the treatment effect of romosozumab on the incidence of new on-study vertebral fractures according to Genant severity grades (mild, moderate and severe), using data from two phase 3 clinical studies. In FRAME, participants were assigned romosozumab or placebo for 12 months, followed by denosumab (Prolia, Amgen) for 24 months. In ARCH, participants were assigned romosozumab for 12 months, followed by alendronate for 24 months, or alendronate alone for 24 months. Researchers assessed the treatment effect of romosozumab for all participants and those with prevalent and severe baseline vertebral fractures.
Researchers found the incidence of new moderate or severe vertebral fractures was reduced through 12 months for participants assigned romosozumab vs. placebo (FRAME; 0.25% vs. 1.42%; P < .001) or alendronate (ARCH; 2.78% vs. 4%; P = .042).
Additionally, the treatment effect of romosozumab on the incidence of new vertebral fractures across moderate and severe severity grades was independent of baseline vertebral fracture prevalence or severity. Through 12 months, consistent reductions in new moderate or severe vertebral fractures were observed regardless of prevalent (FRAME; P = .18) or severe (ARCH; P = .52) vertebral fractures at baseline.
Reductions in the incidence of new moderate and severe vertebral fractures were sustained through 24 months after a transition from romosozumab to denosumab or alendronate, independent of baseline vertebral fracture prevalence or severity.
The researchers noted the analysis is the first to evaluate treatment effects across severity grades of new vertebral fractures, but they added that the data cannot be extrapolated beyond patients who receive romosozumab as a first-line treatment.
“The data reported here further characterize the previously reported efficacy of romosozumab for the reduction of vertebral fracture risk, and support that for postmenopausal women at very high fracture risk, romosozumab treatment for 1 year, followed by an antiresorptive agent, provides sustained reductions across vertebral fracture severity grades, in particular the moderate and severe grades, in patients with and without vertebral fractures at baseline,” the researchers wrote.