Does an educational leaflet improve self-reported adherence to therapy in osteoporosis? The OPTIMA study

Introduction: Adherence to treatment in osteoporosis remains poor. The aim of this study was to evaluate the effects of an educational leaflet on adherence to medication and to assess the association between adherence and health-related quality of life (HRQOL). Methods: A naturalistic, observational, multi-center, prospective study of 12 months' follow-up was performed. Consecutive post-menopausal women aged 50 years to 86 years starting treatment with raloxifene according to daily practice were enrolled from 126 primary care offices in Spain. The women were assigned to two study groups. Group A received an educational leaflet with general information about osteoporosis; group B followed current practice. To assess adherence to medication and HRQOL, the Morisky test and the EuroQoL questionnaire were administered. A total of 745 post-menopausal women (group A, n=366; group B n=379), with a mean age of 62 years, were included. Results: Most patients in both study groups showed high adherence to raloxifene at the 3-month visit: 56.3% vs 62.7% for groups A and B, respectively; this proportion at the 12-month visit was 47.4% (P=0.15) and 52.5% (P=0.02), respectively. At baseline, "pain/discomfort" was the dimension showing the highest percentage of women reporting problems: 86.4% vs 83.2% in groups A and B, respectively (P=0.22). HRQOL improved in both groups throughout the study, with an overall mean increment in the EuroQoL visual analog scale (EQ VAS) of 9.2 at 12 months (P < 0.01). Correlations between adherence and HRQOL were weak. After receiving an educational leaflet, young post-menopausal women suffering osteoporosis did not show improvement in adherence to therapy. HRQOL improved at 12-month follow-up under treatment. Conclusion: No consistent correlation between adherence and HRQOL was found.