Trends in postmenopausal osteoporosis treatment in France during the period 2007-2016: A nationwide claims database analysis.

PURPOSE: To describe the trends in the pharmacological management of postmenopausal osteoporosis in France during the period 2007-2016. METHOD: This cross-sectional, yearly repeated study of patients in France used the nationwide claims database 'Échantillon Généraliste de Bénéficiaires' (EGB), covering a 1 in 97 representative sample of approximately 600,000 individuals insured by the main French public insurance scheme. For women aged 50-89 years, prescriptions for all anti-osteoporosis medications (AOMs) marketed in France during the study period (bisphosphonates alone or used in combination with calcium, selective estrogen receptor modulators, strontium ranelate, teriparatide or denosumab) were identified in each calendar year. Initiation of any AOM in a calendar year was defined by the absence of a prescription for any AOM within the 2 previous calendar years. Incidence was calculated for all AOM prescriptions and initial prescriptions for AOM. RESULTS: Marked changes were observed in the rates of women receiving any AOM, with a slight increase from 2007 to 2009 (from 10.22 to 10.42 per 100 patient-years [PY]), then a plateau in 2009-2010, followed by a rapid and more than twofold decrease until 2016 (from 10.39 to 5.02 per 100 PY). The decrease in the overall rate of women initiating an AOM showed a rapid halving from 2007 to 2012 (from 2.56 to 1.15 per 100 PY), followed by a plateau in the range of 0.90-1.0 per 100 PY during the period 2013-2016. In contrast, the use of calcium/vitamin D has been rapidly increasing as the only prevention and exclusive intervention for postmenopausal osteoporosis, from 10.6% of women in 2007 to 47.7% in 2016. The profile of patients initiating AOM changed substantially over the 10-year period. Despite a stable mean age of approximately 69 years, an increasing proportion of women with severe chronic comorbidities (from 34.9% to 43.3%), history of fractures (from 7.8% to 13.3%) or high-dose steroid use (from 2.9% to 8.4%) was observed. The decline of AOM initiation was associated with a marked reduction of prescriptions during the study period: by 64.2% for primary care physicians; by 36.7% for specialty doctors; and by 18.4% for rheumatologists. CONCLUSION: These findings suggest a general trend toward an AOM uptake that is increasingly limited to a fraction of patients who are at high risk of fractures. In the context of an aging population and declining prescription rates for AOM, these data highlight an increasing treatment gap among women in France with osteoporosis, which is similar to that seen in other European countries and in the USA.

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.