Romosozumab linked to 'substantial gains' in hip, lumbar spine bone mineral density
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Romosozumab as a first treatment produces ‘substantial gains’ in hip and lumbar spine bone mineral density within 1 year, a result that is augmented by then transitioning to a potent antiresorptive, according to a study.
“For almost 2 decades we have had at least one anabolic medication — bone building/teriparatide — as well as multiple antiresorptive medications, which prevent bone deterioration, for treatment of osteoporosis,” Felicia Cosman, MD, of the Columbia University College of Physicians and Surgeons, in New York, told Healio Rheumatology. “However, we learned over the last few years that with teriparatide, the sequence of treatment matters. We get a significantly superior benefit to bone mass and bone strength when teriparatide is given first and antiresorptive medications are given subsequently.”
“Since then, we have had two more anabolic medications come on the market — abaloparatide and romosozumab,” she added. “With both agents, rapid reductions in fracture risk and large bone mineral density increments are seen when the anabolic agent is given first and then followed by an antiresorptive medication — alendronate or denosumab. Since romosozumab has a very different mechanism of action compared to both teriparatide and abaloparatide, we did not know if treatment sequence would be as important for this agent.”
To determine whether the impact on bone mineral density would differ depending on when romosozumab (Evenity, Amgen) was administered — either as the first treatment or a second option, after an antiresorptive medication — among women with osteoporosis, Cosman and colleagues analyzed data from four recent, large-scale trials. In two of these trials — the phase-3 ARCH and FRAME studies — participants received romosozumab prior to an antiresorptive. The other two trials — the phase-3 STRUCTURE study and a phase 2 study — administered the drug following antiresorptive therapy.
The researchers assessed the percentage change in bone mineral density from baseline using an ANCOVA for the data in the FRAME study, summary statistics for data from the phase-2 trial, and a repeated measures model, adjusting for baseline covariates, for data from the ARCH and STRUCTURE studies.
According to Cosman and colleagues, total hip bone mineral density increased 6.2% with 1 year of romosozumab, and by a total of 7.1% with the 2-year romosozumab-then-alendronate sequence, in the ARCH study. In the FRAME trial, patients gained 6.8% with 1 year of romosozumab, and a total of 8.8% with the 2-year romosozumab-then-denosumab sequence.
Meanwhile, patients in the STRUCTURE trial, who previously received alendronate for at least 1 year, gained 2.9% in hip bone mineral density with 1 year of romosozumab. In the phase 2 study, following 1 year of denosumab, romosozumab for 1 year increased bone mineral density in the hip by 0.9%, for a total gain of 3.8% with the 2-year denosumab-then-romosozumab sequence.
Regarding the lumbar spine, bone mineral density increased 13.7% with 1 year of romosozumab, and a total of 15.2% with the 2-year romosozumab-then-alendronate sequence, in the ARCH trial. In the FRAME study, patients gained 13.3% with 1 year of romosozumab and a total of 17.6% with the 2-year romosozumab-then-denosumab sequence.
Patients in the STRUCTURE trial, after receiving on alendronate for at least 1 year prior, gained 9.8% in lumbar spine bone mineral density with 1 year of romosozumab. In the phase 2 study, after 1 year of denosumab, a year of romosozumab increased bone mineral density there by 5.3%, for a total gain of 11.5% with the 2-year denosumab-then-romosozumab sequence.
“The study is important because it suggests that for all three of the bone-building drugs, the best effects will be attained if the agents are used as initial therapy in high-risk patients, including those who have sustained fractures within the last 2 years or those who have had multiple fractures at any time in adulthood, as well as those with very low bone mineral density, especially if they also have clinical risk factors,” Cosman said.
“But one other important message here is that romosozumab does still work well after antiresorptive treatment with alendronate, and produces a bone mineral density and bone strengthening effect which is significantly better than teriparatide in these patients in a direct head-to-head study,” she added. “Romosozumab also produces a bone mineral density benefit in people who transition from denosumab, which is also much better than observed in another study when patients were transitioned from denosumab to teriparatide.”
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Cosman F. Abstract 1973. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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