Effects of Zoledronic Acid After a Fragility Fracture: The Fragility Fracture Trial

Background: Each year, fractures affect 95,000 older adults in Sweden. Less than 10% of these adults receive bone-strengthening treatment to prevent new fractures.

This low prescription rate is probably influenced by the fact that few clinical trials have examined whether bone-strengthening treatment is effective after a fracture, and no trial has examined whether treatment is effective after a fracture not of the hip or vertebrae, which constitute the majority of fractures.Purpose and aim: This study will investigate whether zoledronic acid, a widely used bone-strengthening agent, is more effective than placebo in reducing fractures among older adults who have previously suffered a non-hip, non-vertebral fragility fracture.

Methods: We will recruit 2,900 men and women, 65-years of age or older, with a recent non-hip, non-vertebral fragility fracture to a multicenter, randomized controlled trial across Sweden.

Each participant will be randomized to receive 2 intravenous infusions of zoledronic acid (5 mg) or placebo, given at baseline and at 2-years. Participants will then be followed up every 6 months for 4-years. The primary outcome will be any new clinical fracture.

Importance: Fractures in older adults are both costly for health care systems and major contributors to morbidity and mortality.

Since there is little evidence that bone-strengthening treatment is effective after a fracture, the results of this study will have a direct impact on the care of fracture patients.