Romosozumab reduces vertebral fracture risk in postmenopausal osteoporosis
Click Here to Manage Email Alerts
Women with postmenopausal osteoporosis who received the monoclonal antibody romosozumab were less likely to sustain a vertebral fracture during 12 months of treatment compared with women who received placebo or alendronate, study data show.
“Treatment with romosozumab significantly reduces the incidence of new vertebral fractures in two phase 3 studies, FRAME and ARCH,” Robert Feldman, MD, of Senior Clinical Trials Inc., in Laguna Hills, California, said during a presentation at ENDO Online. “In both studies, observed reductions in vertebral fractures persisted beyond 12 months of treatment with romosozumab after patients were transitioned to treatment with a different antiresorptive agent, either denosumab biannually or alendronate weekly, respectively.”
Vertebral fractures are the most common type of fracture in postmenopausal osteoporosis and are generally classified using the Genant grading system as mild (grade 1), moderate (grade 2) or severe (grade 3) according to their degree of compression as seen on spinal X-rays, Feldman said. Regardless of their severity, vertebral fractures are associated with morbidity and carry the highest subsequent fracture rate of any fragility fracture, he said.
In a post hoc analysis, Feldman and colleagues analyzed data from 7,180 postmenopausal women participating in FRAME who were randomly assigned 210 mg monthly romosozumab-aqqg (Evenity, Amgen) or placebo for 12 months, followed by 60 mg biannual denosumab (Prolia, Amgen) or placebo for 12 months. The researchers also analyzed data from 4,093 postmenopausal women with at least one fracture participating in ARCH who were randomly assigned 210 mg monthly romosozumab or 70 mg weekly oral alendronate for 12 months, followed by 70 mg alendronate for at least 12 months.
During the two studies, participants underwent lateral radiographs of the spine to assess for presence and severity of vertebral fracture using Genant grading at baseline, 12 and 24 months.
Researchers found that the incidence of new vertebral fractures was lower among patients who received romosozumab during the 12-month double-blind treatment phase in both studies.
During the first 12 months, incidence of new vertebral fractures was 0.5% and 1.8% for the romosozumab and placebo groups, respectively, in FRAME (P < .001), and 3.2% and 5% for the romosozumab and alendronate groups, respectively, in ARCH (P = .008).
Over 24 months, incidence of new vertebral fracture was 0.6% and 2.5%, respectively, for women who transitioned from romosozumab to denosumab and those who transitioned from placebo to denosumab (P < .001) in FRAME. In ARCH, incidence of new vertebral fracture was 4.1% and 8%, respectively, for women who transitioned from romosozumab to alendronate and women who maintained alendronate therapy (P < .001).
“Fewer new vertebral fractures were observed in the romosozumab arms of both studies across all fracture severity grades,” Feldman said.
In FRAME, incidence of severe vertebral fractures at 12 months was 0.2% and 0.5%, respectively, for the romosozumab and placebo arms, and 0.2% and 0.6%, respectively, for the same groups at 24 months. In ARCH, incidence of severe vertebral fractures at 12 months was 1.5% and 1.9%, respectively, for the romosozumab and alendronate arms, and 1.9% and 3.3%, respectively, for the same groups at 24 months.
“Romosozumab administered over 12 months to women with postmenopausal osteoporosis resulted in reductions in vertebral fractures across all fracture severity grades compared with placebo and standard-of-care alendronate,” Feldman said. “The treatment effect of romosozumab continued after patients transitioned to an antiresorptive agent. These data will help to foster treatment decisions in postmenopausal women at high risk for vertebral fractures.”
Collapse
Feldman R, et al. Romosozumab Treatment lowers the incidence of new vertebral fractures across all fracture severity grades among postmenopausal women with osteoporosis. ENDO Online; June 8-19, 2020.
Click Here to Manage Email Alerts