Abstract
ABSTRACTRadiographic vertebral fractures (VFxs) are the most common fractures in osteoporosis and are associated with increased morbidity, mortality, and costs. A subset of VFxs manifest clinically, usually with a sudden onset of severe back pain. Romosozumab is a monoclonal antibody that binds and inhibits sclerostin, increasing bone formation and decreasing bone resorption, leading to rapid and large increases in bone density and strength and reduction in fracture risk. The FRAME (Fracture Study in Postmenopausal Women with Osteoporosis) study of postmenopausal women with osteoporosis demonstrated a significant reduction in new VFxs with romosozumab versus placebo. Here, we report the effect of romosozumab versus placebo on clinical VFx incidence over 12 months in women reporting back pain suggestive of VFxs. FRAME enrolled 7180 postmenopausal women with osteoporosis, mean age 70.9 years (hip T‐score −2.5 to −3.5). In the first year of the study, women received monthly romosozumab 210 mg (n = 3589) or placebo (n = 3591). At regular monthly visits, women reporting back pain suggestive of a clinical VFx had a confirmatory spine X‐ray. Clinical VFx risk in the romosozumab group versus the placebo group was calculated by Cox‐proportional hazards model. Of 119 women in FRAME with back pain suggestive of a clinical VFx over 12 months, 20 were confirmed to have experienced a new/worsening VFx. Three women receiving romosozumab had a clinical VFx (<0.1% of 3589 women) versus 17 (0.5% of 3591 women) receiving placebo resulting in a reduction in clinical VFx risk of 83% in the romosozumab group versus placebo through 12 months (HR 0.17; 95% CI, 0.05 to 0.58; p = 0.001). In the three romosozumab‐treated women, clinical VFxs occurred within the first 2 months of the study with no further clinical VFxs throughout the year. Romosozumab treatment for 12 months was associated with rapid and large reductions in clinical VFx risk versus placebo. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
Highlights
Vertebral fractures fractures and are (VFxs) are the hallmark the most common fragility of osteoporosis, indicating a deficit in bone mass and microstructural deterioration.[1]
17 new clinical VFxs occurred through 12 months; relative risk reduction (RRR) for romosozumab versus placebo was 83%; (HR 0.17; 95% CI, 0.05 to 0.58; p = 0.001; Fig. 1B)
All of the clinical VFxs in the romosozumab group, and the majority (82%) of the clinical VFxs in the placebo group, were moderate or severe. In this post hoc analysis of the Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) study, 12 months of romosozumab treatment led to a significant reduction in the incidence of clinical VFxs, which in the romosozumab group were only observed during the first 2 months of treatment, with no additional clinical VFx for the remainder of the 12‐ month treatment period
Summary
Vertebral fractures fractures and are (VFxs) are the hallmark the most common fragility of osteoporosis, indicating a deficit in bone mass and microstructural deterioration.[1]. They are associated with increased mortality, morbidity, and costs.[2,3]. Romosozumab is a monoclonal antibody that binds and inhibits sclerostin.[10] It exerts a dual effect on bone by increasing bone formation and decreasing bone resorption.[10]. In the FRAME study, romosozumab resulted in a significant reduction in new VFxs and clinical fractures through 12 months compared with placebo. The relative risk reduction (RRR) on radiographic VFxs was 73% (p < 0.001).(11) During the first year of the FRAME study, women attended monthly follow‐up visits allowing clinical VFxs to be identified in a timely manner.[11]. In this prespecified exploratory study of FRAME, we analyzed the time‐to‐event for clinical VFxs in the romosozumab and placebo arms within 1 year
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