Effects of Romosozumab Compared With Teriparatide on Bone Density and Mass at the Spine and Hip in Postmenopausal Women With Low Bone Mass |
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| Authors: | Harry K Genant Klaus Engelke Michael A Bolognese Carlos Mautalen Jacques P Brown Chris Recknor Stefan Goemaere Thomas Fuerst Yu‐Ching Yang Andreas Grauer Cesar Libanati |
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| Institution: | 1. University of California, San Francisco (UCSF), San Francisco, CA, USA;2. BioClinica‐Synarc, San Francisco, CA, USA;3. BioClinica, Hamburg, Germany;4. Institute of Medical Physics, University of Erlangen, Erlangen, Germany;5. The Bethesda Health Research Center, Bethesda, MD, USA;6. Centro de Osteopatias Medicas, Buenos Aires, Argentina;7. CHU de Québec Research Centre and Laval University, Québec, QC, Canada;8. United Osteoporosis Centers, Gainesville, GA, USA;9. Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, Ghent, Belgium;10. BioClinica Inc., Newark, CA, USA;11. Amgen Inc., Thousand Oaks, CA, USA;12. UCB BioPharma, Brussels, Belgium |
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| Abstract: | Romosozumab, a monoclonal antibody that binds sclerostin, has a dual effect on bone by increasing bone formation and reducing bone resorption, and thus has favorable effects in both aspects of bone volume regulation. In a phase 2 study, romosozumab increased areal BMD at the lumbar spine and total hip as measured by DXA compared with placebo, alendronate, and teriparatide in postmenopausal women with low bone mass. In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab (210 mg once monthly). QCT measurements were performed at the lumbar spine (mean of L1 and L2 entire vertebral bodies, excluding posterior processes) and hip. One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05). Trabecular vertebral vBMD improved significantly and similarly from baseline (p < 0.05) with both romosozumab (18.3%) and teriparatide (20.1%), whereas cortical vertebral vBMD gains were larger with romosozumab compared with teriparatide (13.7% versus 5.7%, p < 0.0001). Trabecular hip vBMD gains were significantly larger with romosozumab than with teriparatide (10.8% versus 4.2%, p = 0.01), but were similar for cortical vBMD (1.1% versus –0.9%, p = 0.12). Cortical BMC gains were larger with romosozumab compared with teriparatide at both the spine (23.3% versus 10.9%, p < 0.0001) and hip (3.4% versus 0.0%, p = 0.03). These improvements are expected to result in strength gains and support the continued clinical investigation of romosozumab as a potential therapy to rapidly reduce fracture risk in ongoing phase 3 studies. © 2016 American Society for Bone and Mineral Research. |
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| Keywords: | OSTEOPOROSIS BONE QCT CLINICAL TRIALS ANABOLICS |
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