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Romosozumab increases bone mass, density at spine, hip
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Postmenopausal women with osteoporosis assigned the monoclonal antibody romosozumab saw improved bone mineral density and bone mass at the lumbar spine and total hip, study data show.
Harry K. Genant, MD, professor emeritus of radiology, orthopedic surgery, medicine and epidemiology at the University of California at San Francisco, and colleagues evaluated data from postmenopausal women randomly assigned to placebo (n = 27), subcutaneous teriparatide (Forteo, Lilly) 20 µg once per day or subcutaneous romosozumab (n = 24; Amgen/UCB Pharma) 210 mg once per month to determine the effect of each agent on lumbar spine and hip volumetric BMD and bone mineral content (BMC) after 12 months.
DXA and quantitative CT were used to measure changes at the lumbar spine and hip.
DXA areal BMD and BMC at the lumbar spine and total hip were increased at 12 months in the romosozumab group compared with placebo (P < .01) and teriparatide (P < .05). The mean percentage increase in integral lumbar spine BMD was greatest in the romosozumab group (17.7%) compared with a 0.8% increase in the placebo group (P < .0001) and a 12.9% increase in the teriparatide group (P = .002). The romosozumab group had significant increases in integral BMC (17.7%) compared with a 1% decrease in the placebo group and 12.8% increase in the teriparatide group.
At month 12, the mean percentage increase in volumetric BMD at the total hip was greater with romosozumab (4.1%) compared with placebo (0.3%) and teriparatide (1.2%). The same was true for BMC (romosozumab, 4.7%; placebo, 1.1%; teriparatide, 0.8%).
Compared with placebo, romosozumab increased trabecular volumetric BMD at the lumbar spine and total hip (P < .0001 for both); results were similar between romosozumab and teriparatide for lumbar spine but were greater with romosozumab for total hip (P = .011). Cortical volumetric BMD at the lumbar spine was increased with both romosozumab and teriparatide compared with placebo (P < .0001 for both). Romosozumab resulted in greater increases in cortical volumetric BMD at the total hip (1.1%) compared with teriparatide (–0.9%), but this was not significant.
Romosozumab increased cortical BMC at the lumbar spine compared with placebo and teriparatide (P < .0001 for both) and at the total hip compared with teriparatide (P = .034).
“Romosozumab, a novel anabolic agent for treatment of severe osteoporosis, was shown in this study, using advanced quantitative CT, to positively enhance the BMD and BMC of both the trabecular and cortical compartments of the hip and spine, relative to teriparatide and placebo,” Genant told Endocrine Today. “Using advanced quantitative CT technology, the very promising bone effects of this new osteoporotic therapy are well defined and documented.” – by Amber Cox
For more information:
Harry K. Genant, MD, can be reached at harry.genant@ucsf.edu.
Disclosure: Genant reports receiving consulting fees from AgNovos, Amgen, BioClinica-Synarc, BioMarin, Clementia, Janssen, Lilly, Medtronic, Merck, Pfizer, Regeneron and Roche. Please see the full study for a list of all other authors’ relevant financial disclosures.
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