Bone strength, BMD increase more substantially with romosozumab vs. alendronate
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Among a cohort of postmenopausal women randomly assigned to romosozumab or alendronate, larger improvements in bone mineral density and bone strength in the lumbar spine were observed for those taking romosozumab, according to findings presented at the American Society of Bone and Mineral Research annual meeting.
“This research demonstrates the superiority of a new bone-building agent, romosozumab, compared to a commonly used antiresorptive, alendronate, in rapidly and sustainably increasing integral — sum of cortical shell and trabecular bone of the vertebral body — volumetric bone mineral density by quantitative CT and bone strength estimated by quantitative CT/finite element analysis at [the] lumbar spine,” Jacques P. Brown, MD, of CHU de Quebec Research Center of Laval University in Quebec City, told Endocrine Today.
In a subanalysis of the ARCH trial, Brown and colleagues evaluated data from 90 postmenopausal women (mean age, 73 years) with osteoporosis and vertebral fracture history randomly assigned a monthly 210 mg subcutaneous regimen of romosozumab (Evenity, Amgen) or a weekly 70 mg oral regimen of alendronate. Both regimens were followed for 12 months at which point all participants followed the alendronate regimen for another 12 months. At baseline, 6 months, 12 months and 24 months, researchers used quantitative CT to identify changes in BMD and finite element analysis to identify changes in bone strength at the lumbar spine.
When compared against baseline measures, the researchers observed a 17.7% increase in lumbar spine BMD at 6 months for those taking romosozumab vs. a 5.6% increase for those taking alendronate (P < .001). In addition, there was a 21.9% increase in lumbar spine BMD at 12 months for those taking romosozumab compared with a 7.3% increase for those taking alendronate (P < .001). At 24 months, those who began on romosozumab had a 21.4% increase over baseline measures, and those who took alendronate for the entire study period had a 7.9% increase (P < .001).
The researchers further observed a 23.4% increase in lumbar spine bone strength between baseline and 6 months in the romosozumab group compared with a 6.9% increase for those in the alendronate group (P < .001). At 12 months, there was a 28.1% increase from baseline in lumbar spine bone strength in the romosozumab group and a 7.7% increase in the alendronate group (P < .001). Those who initially began on romosozumab had a 25.8% increase in lumbar spine bone strength compared with baseline at 24 months compared with a 3.8% increase for those taking alendronate for the entire study (P < .001).
“The rapid and large increases in BMD with romosozumab followed by BMD consolidation when transitioning to alendronate support the important role of romosozumab as a first-line therapy in treating patients at very high risk for fracture,” Brown said. – by Phil Neuffer
Reference:
Brown JP, et al. Abstract 1050. Presented at: American Society of Bone and Mineral Research; Sept. 20-23, 2019; Orlando.
Disclosure: Brown reports he has received grant and research support from Mereo BioPharma, Radius and Servier, served as a consultant for Amgen, Eli Lilly and Servier and served on the speakers bureau for Amgen and Eli Lilly.
Perspective
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Bart L. Clarke, MD
This interesting study suggests that anabolic therapy with romosozumab increases bone density and bone strength more effectively than antiresorptive therapy with alendronate. The study followed 90 postmenopausal women randomized to romosozumab 210 mg subcutaneously each month vs. alendronate 70 mg orally once a week for 12 months, followed by alendronate in all participants for another 12 months, in a subanalysis of the ARCH study. Volumetric bone density was followed by quantitative CT measurement, and bone strength by finite element analysis (FEA). By 12 months, the women treated with romosozumab increased their bone density by 21.9%, whereas the women treated with alendronate increased their bone density by 7.3%. These increases were slightly greater by 24 months, after all women were maintained on alendronate for another 12 months. Bone strength estimated by FEA increased by 28.1% in those treated with romosozumab, and 7.7% in those treated with alendronate, at 12 months. No fracture data were available for this subanalysis. These findings suggest that anabolic therapy first may increase bone density and bone strength more rapidly than standard antiresorptive therapy. These observations may lead to a change in the paradigm for treatment of postmenopausal osteoporosis, where antiresorptive therapy is usually given first.
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