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Romosozumab Followed by Denosumab Decreased Fracture Risk in Postmenopausal Women
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The risks for new vertebral, clinical and nonvertebral fractures were reduced and bone mineral density increased in postmenopausal women assigned romosozumab followed by denosumab, according to results from the FRAME extension study presented at the American Society for Bone and Mineral Research Annual Meeting.
In the original FRAME study, 7,180 postmenopausal women were assigned to receive subcutaneous placebo or romosozumab (Amgen/UCB Pharma) monthly for 12 months followed by open-label subcutaneous denosumab (Prolia, Amgen) every 6 months for 12 months.
“The sequence of treatment is important,” E. Michael Lewiecki, MD, FACP, FACE, director of the New Mexico Clinical Research and Osteoporosis Center in Albuquerque, told Endocrine Today. “Anabolic therapy must be followed by antiresorptive therapy to consolidate and enhance benefits achieved. This study showed that the BMD response to denosomab after romosozumab was robust and that the fracture risk reduction was greater with this sequence than with denosumab after placebo. Romosozumab followed by denosumab appears to be a promising regimen for the treatment of postmenopausal osteoporosis.”
Lewiecki and colleagues evaluated data from the FRAME study on postmenopausal women randomly assigned placebo followed by denosumab (n = 2,892) or romosozumab followed by denosumab (n = 2,851) to determine incidence of new vertebral, clinical and nonvertebral fractures and BMD changes through 36 months. Participants who received romosozumab followed by denosumab had reduced risks for new vertebral, clinical, nonvertebral and other predefined fracture endpoints compared with participants assigned to placebo followed by denosumab through 36 months.
BMD increased by 18.1% from baseline at the lumbar spine and by 9.4% at the total hip in the romosozumab followed by denosumab group. Through the 36 months, the mean differences in BMD remained between the two groups (P < .001).
Rates of adverse events were similar between the two groups.
“The 36-month extension of FRAME showed that romosozumab for 12 months followed by denosumab for 24 months resulted in greater increases in BMD and greater reduction in fracture risk than placebo for 12 months followed by denosumab for 24 months,” Lewiecki said. “Further study is needed to evaluate the benefits and risks of romosozumab in special populations, such as those with glucocorticoid-induced osteoporosis and patients previously treated with teriparatide or abaloparatide. Possible cardiovascular safety concerns, which were reported in another study but not in FRAME, need further assessment.” – by Amber Cox
Reference:
Lewiecki EM, et al. Abstract 1071. Presented at: American Society for Bone and Mineral Research Annual Meeting; Sept. 8-11, 2017; Denver.
Disclosure: Lewiecki reports he has financial ties with Amgen, Eli Lilly, Merck and Radius.