ECTS2013 Oral Communications Treatment of osteoporosis (6 abstracts)
Effects of romosozumab administration on trabecular and cortical bone assessed with quantitative computed tomography and finite element analysis
C Graeff 1, , G Campbell 2 , J Peña 2 , D Padhi 3 , A Grossman 3 , S Chang 3 , C Libanati 3 & C-C Glüer 2
1GSI, Darmstadt, Germany; 2Sektion Biomedizinische Bildgebung, Klinik für Radiologie, UKSH, Kiel, Germany; 3Amgen, Inc., Thousand Oaks, California, USA.
Romosozumab is an investigational bone-forming agent that inhibits sclerostin. Recent data demonstrated that it stimulated bone formation, decreased bone resorption, and led to rapid and substantial increases in areal bone mineral density (BMD; McClung, J Bone Miner Res 27 (S1) S8–S9, 2012). In a Phase 1b, randomized, double-blind, placebo-controlled, multiple dose study, we studied the effects of romosozumab administered for 3 months and follow-up of 3 months after the last dose (month 6), in a group of 16 men (12 romosozumab, 4 placebo) and 32 women (24 romosozumab, 8 placebo). Quantitative computed tomography (QCT) was obtained at L1–2 in 24 subjects on romosozumab and 9 subjects on placebo and high resolution QCT (HRQCT) at T12 in a subset of 11 subjects on romosozumab and 3 subjects on placebo. The analyses pooled all romosozumab doses (1 mg/kg every 2 weeks, 2 mg/kg every 2 weeks, 2 mg/kg every 4 weeks, and 3 mg/kg every 4 weeks). Linear finite element modeling of bone stiffness was performed with both QCT and HRQCT data. Repeated measures mixed models were calculated and results expressed as least-square means±S.E.M. Compared with placebo, the romosozumab group showed improvements at both months 3 and 6 for trabecular BMD by QCT and HRQCT (all P<0.01), HRQCT-based density-weighted cortical thickness (dwCort.Th, P<0.001), and HRQCT-based stiffness (P<0.05). Three months following the last romosozumab dose, there were further improvements in HRQCT-based trabecular BMD and dwCort.Th (all P<0.05). The improvement in HRQCT-based stiffness with romosozumab administration from baseline was 25.9±6.7 and 34.0±6.7% at months 3 and 6 respectively; placebo subjects had changes of 0.9±12.8 and 2.7±12.8% respectively. In conclusion, romosozumab administered for 3 months resulted in very rapid and large increases in trabecular and cortical bone and bone stiffness, which continued to accrue in the 3 months following the last dose of romosozumab.
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