Health-related quality of life and treatment of postmenopausal osteoporosis: results from the HORIZON-PFT.

Osteoporosis-related fractures are associated with reductions in health-related quality of life (HRQL). We examined the benefits of zoledronic acid (ZOL) on HRQL in patients sustaining vertebral and clinical fractures from HORIZON-Pivotal Fracture Trial using mini-Osteoporosis quality of life Questionnaire (OQLQ). In this multicenter, double-blind, placebo-controlled trial, 1434 patients from a cohort of postmenopausal women with osteoporosis (mean age 73years) were randomized to receive annual infusions of ZOL 5mg or placebo for 3years. Baseline HRQL scores were comparable between ZOL and placebo groups based on the presence or absence of fractures, with exception of prevalent vertebral fractures where patients (irrespective of the treatment group) had lower baseline HRQL scores than those without prevalent vertebral fractures. Greater number of prevalent vertebral fractures was associated with lower baseline HRQL (p<0.001). No significant difference between ZOL and placebo in the overall summary score was observed but a significant benefit was noted in certain domains with ZOL, especially in patients sustaining incident clinical fractures. Improvements in HRQL were marked at first assessment after a morphometric vertebral fracture with significant differences favouring ZOL in pain (p=0.0115), standing pain (p=0.0125)), physical (lifting, p=0.0333) and emotional function (fear of fractures, p=0.0243; fear of falls, p=0.0075) but not for activities of daily living or leisure domains. HRQL is reduced in patients with vertebral fractures. Treatment with ZOL over 3years was associated with improvements in specific domains of quality of life vs. placebo, particularly in patients sustaining incident fractures.

RCT Entities:   Population Interventions Outcomes