Outcomes

The primary outcome consisted of two elements: (1) persistence with denosumab, defined as no more than 60 days between scheduled injections at 12, 18, and 24 months: and (2) time to non-persistence (discontinuation) at 12, 18, and 24 months, defined as the total number of days between the first denosumab injection and the date a patient became non-persistent. Patients who discontinued the study were considered non-persistent.

Secondary outcomes included baseline demographics and disease characteristics; number of denosumab injections received during follow-up; change in BMD T-score and raw T-score over time; osteopenia (− 2.5 ≤ T < − 1.5) or complete recovery [T-score ≥ − 1.5] at the femoral neck, lumbar spine, and total hip; BMD changes from baseline at the femoral neck, lumbar spine, and total hip of ≤ 0%, > 0 to ≤ 3%, > 3% to ≤ 6% and > 6% after 24 months; fractures and adverse drug reactions (ADRs; safety events observed by the investigator or reported by the patient that occurred during follow-up).