The drug romosozumab has posted positive results in the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME) trial, according to UCB and Amgen.
The data showed that romosozumab met its co-primary endpoints by reducing the incidence of new vertebral fracture through months 12 and 24 in postmenopausal women with osteoporosis.
The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. However, the secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met.
Results from the FRAME study showed that women receiving a monthly subcutaneous injection of romosozumab experienced a statistically significant 73% reduction in the relative risk of a vertebral (spine) fracture through 12 months compared to those receiving placebo.
The effect size persisted after both groups were transitioned to denosumab through the second year of treatment. Specifically, through month 24, romosozumab followed by denosumab reduced the relative risk of new vertebral fractures by a statistically significant 75% compared to placebo followed by denosumab. Additionally, patients receiving romosozumab experienced a statistically significant 36% reduction in the relative risk of a clinical fracture through 12 months compared to those receiving placebo.
The percentage of patients with adverse events and serious adverse events in the 12-month double-blind period and 24-month study period were balanced overall between the treatment groups.
In the initial 12-month treatment period, the most commonly reported adverse events in both arms (greater than 10%) were arthralgia, nasopharyngitis and back pain. Injection site reactions were reported in 5.2% of patients in the romosozumab treatment group and 2.9% in the placebo group during the 12-month period. Most injection site reactions were reported as mild in severity. Sub-studies evaluating hearing loss and worsening of knee osteoarthritis showed no difference between the treatment groups. There were two positively adjudicated events of osteonecrosis of the jaw in the romosozumab treatment group, one after completing romosozumab dosing and the other after completing romosozumab treatment and receiving the initial dose of denosumab. There was one positively adjudicated event of atypical femoral fracture after three months of romosozumab treatment.
Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President,UCB, said: “These data are encouraging and in meeting the co-primary endpoints of this study, romosozumab has shown to be effective in reducing the incidence of new vertebral fractures at months 12 and 24 and for clinical fractures as early as 12 month.
“Deeper understanding of the results will help us sharpen the profile of romosozumab in postmenopausal women with osteoporosis.”
Sean E. Harper, MD, Executive Vice President of Research and Development at Amgen, added: “A vertebral fracture due to osteoporosis can be a life-altering event, and the risk of these kinds of fractures will be a growing burden as our society ages. These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months.”