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.

Automated summary

In a real-world clinical practice in France, postmenopausal women with osteoporosis showed high persistence with denosumab at 12 and 24 months, with a good tolerability profile.