Abstract

BackgroundData from randomized clinical trials showed that anti-osteoporotic treatments increase bone mineral density (BMD) and reduce the risk of fragility fractures. However, data on the real-life effectiveness of such medications is still scarce.ObjectivesThe primary objective of the present study is to assess the real-life effectiveness of anti-osteoporotic treatment in a representative cohort of Italian women at high risk of fractureMethodsWe conducted a cohort study on women at high risk of fracture. We retrieved clinical and densitometric data from the DeFRA database, which derives from the DeFRA tool, a web-based fracture risk assessment tool. Multivariable Cox regression survival models were employed to analyze the effectiveness of different anti-osteoporotic drugs on fracture. In sensitivity analyses we generated 1:1 matched cohorts of patients with prescription of bisphosphonates, denosumab, teriparatide or without any pharmacological prescription at baseline and 1:1 matched cohort based on the T-score variation over the time (increase in T-score vs decrease or stability in T-score values).ResultsData from 50,862 women were available. Among these, 3,574 individuals had at least 2 consecutive visits. The crude fracture rate was 91.9/1,000 person-year for non-treated patients. The crude fracture rate in bisphosphonate users was 72.1/1,000 person-year, in denosumab users was 58.2/1,000 person-year and in teriparatide users was 19.3/1000 person-year. Overall, we found that bisphosphonates were associated with a 30% lower risk of fracture compared to no treatment (aHR 0.70, 95% CI 0.50-0.98), denosumab and teriparatide were associated with 60% and 90% lower risk of fracture, respectively (aHR 0.43, 95% CI 0.24-0.75 and aHR 0.09, 95% CI 0.01-0.70). Bisphosphonate use was associated with a lower risk of fracture only after one year of treatment. In Figure 1 are presented the Kaplan Meier curves free from fragility fracture after propensity score matching.ConclusionIn conclusion, we found that all anti-osteoporotic medications effectively reduced the risk of fracture in the real-life. Bisphosphonate’s effect on fracture risk was apparent only after the first year of treatment. Our findings do not support the use of bisphosphonates in patients at imminent risk of fracture.Disclosure of InterestsGiovanni Adami Shareholder of: Theramex, Galapagos, IRENE GAVIOLI: None declared, Angelo Fassio: None declared, Camilla Benini: None declared, Eugenia Bertoldo: None declared, Ombretta Viapiana: None declared, Davide Gatti: None declared, Maurizio Rossini Shareholder of: Abbvie, Amgen, Bms, Eli Lilly, Galapagos, Novartis, Pfizer, Sandoz, Theramex, Ucb.

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