High persistence over two years with denosumab among postmenopausal women with osteoporosis in France: A prospective cohort study.

PURPOSE: To assess the 12 and 24-month persistence with denosumab in postmenopausal women with osteoporosis in real-world clinical practice in France, and to describe characteristics and management of these patients. METHODS: This prospective, multicenter cohort study evaluated persistence with denosumab at 12 months (primary endpoint) and 24 months (secondary endpoint), defined as at least 2 or 4 injections respectively, and time elapsed between 2 consecutive injections did not exceed 6 months +8 weeks. Other endpoints included patients' characteristics at baseline, medical history, concomitant and previous treatments, and incidence of adverse drug reactions (ADR), serious adverse events and fractures. RESULTS: 478 patients were enrolled by 86 physicians between June 2015 and February 2016. The mean follow-up was 28 months. Mean age was 72 years and 91% of patients had been previously treated for osteoporosis. The persistence with denosumab was 86% (95%CI: 83%-89%) at 12 months and 72% (95%CI: 68%-76%) at 24 months. Using the Kaplan-Meier estimates, the persistence probability over time was 86% at 12 months and 76% at 24 months. During the study, 78 patients discontinued therapy. No multiple vertebral fractures were reported upon discontinuation. ADR were reported for 55 patients, 4 being serious, and 27 patients discontinued denosumab due to an ADR. Among patients who received at least one injection, 10 died. None of the deaths were attributable to denosumab. CONCLUSION: Persistence with denosumab at 12 and 24 months was high, and the treatment was well tolerated among postmenopausal women with osteoporosis treated in routine clinical practice in France.