Frame study: The foundation effect of building bone with 1 year of romosozumab leads to continued lower fracture risk after transition to denosumab
Journal of Bone and Mineral Research Jun 01, 2018
Cosman F, et al. - Considering the FRActure study in postmenopausal woMen with ostEoporosis (FRAME) demonstrating one year of romosozumab as efficacious in increasing spine and hip BMD, and reducing vertebral and clinical fractures with persistent fracture risk reduction upon transition to denosumab over 24 months, researchers performed further characterization of the BMD gains with romosozumab by quantifying the percentages of patients who responded at varying magnitudes. They also reported the mean T-score changes from baseline over the 2 year study and contrasted these results with the long-term BMD gains seen with denosumab during Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) and its Extension studies; and assessed fracture incidence rates in year 2, when all patients received denosumab. Most romosozumab-treated patients experienced ≥3% gains in BMD from baseline at month 12. Mean absolute T-score increases in romosozumab patients at the spine and hip were 0.88 and 0.32, respectively, at 12 months and 1.11 and 0.45 at 24 months. These 2 year gains approximate the effect of 7 years of continuous denosumab administration. Patients receiving romosozumab in year 1 demonstrated significantly fewer vertebral fractures in year 2 (81% relative reduction), with fewer fractures consistently observed across other fracture categories.
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