T ‐Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial

ABSTRACTIn the Active ‐Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) clinical trial (NCT01631214), 1 year of romosozumab followed by alendronate reduced the risk of vertebral and nonvertebral fractures compared to alendronate alone in women with prevalent fracture. We perform ed post hoc analyses of data from patients in ARCH (romosozumab,n =  1739; alendronate,n =  1726) who had a baseline BMD measurement and received at least one open‐label alendronate dose. We evaluated 1‐year mean BMD and correspondingT‐score changes; proportions of patients achievingT‐scores> −2.5 at the total hip (TH), femoral neck (FN), and lumbar spine (LS); and group differences in fracture rates after 12 months, while all participants were on alendronate. Subsequently, we investigated the relationship betweenT‐scores achieved at the TH, FN, and LS at 12 months and subsequent fracture incidence. At 1 year, mean change from baseline in TH BMD was 6.3% (T‐score change 0.31) with romosozumab versus 2.9% (T‐score change 0.15) with alendronate (p<  .001). The proportion of patients with THT‐score> −2.5 increased from 34% at baseline to 55% after 1 year of romosozumab and from 32% at baseline to 44% after 1 year of alendronate. Compared with patients receiving alendronate in year 1, those receiving romosozumab had a 75% reduction in new or worsening vertebral fracture (p<  .001) in year 2, and a 19% reduction in...
Source: Journal of Bone and Mineral Research - Category: Orthopaedics Authors: Tags: Original Article Source Type: research