Fracture ascertainment
fracture, fractures, primary fracture
EVENTS, SECONDARY
During annual visits and telephone calls every 6 months, staff members who were unaware of study-group assignments (blinded) queried participants about all medical events and hospitalizations including incident fractures. Hospital and other records such as outpatient medical records and x-ray reports were reviewed for potential incident fracture events, with adjudication according to standard criteria by a central review committee of trained physicians who were blinded to study-group assignment. The primary fracture outcome was prespecified as the first occurrence of a fracture. Self-reported fractures of the fingers, toes, face, neck (c-spine), sternum, ribs, and skull were not centrally adjudicated and are not included in the fracture events for this manuscript. Only confirmed centrally adjudicated incident fracture events are included in these analyses. As a secondary fracture outcome, a frailty fracture endpoint was created a priori and is a composite of the first occurrence of a hip, pelvis, upper arm or shoulder fracture [