Efficacy and safety of once monthly ibandronate treatment in patients with reduced bone mineral density--ESTHER study.

INTRODUCTION Osteoporosis usually affects post-menopausal women. Treatment is individualized and requires an approach that will provide long-term compliance to prevent fractures. Studies conducted so far suggest inadequate compliance and persistence in weekly bisphosphonate treatment (under 43% after a year of treatment). Ibandronate, as a powerful bisphosphonate, has made it possible for the first time to treat osteoporosis with a single tablet per month. OBJECTIVE Study of efficacy, safety and tolerance of ibandronate applied once a month in female patients with decreased bone mineral density (BMD). METHODS The prospective study was conducted in 34 centres in Serbia covering the total of 370 women with reduced BMD with ibandronate once a month. Demographic data, risk factors for osteoporosis, mode of diagnosis establishment, previous treatment for osteoporosis and concomitant diseases were investigated. Efficacy of the treatment was evaluated by T-score value after 12 months versus the baseline values. Tolerance of the treatment, compliance and adverse effects were recorded. RESULTS The sample included 97.5% post-menopausal women, 92.7% with osteoporosis. In 80% of the cases, the diagnosis was established by DXA measurement. In more than 90% of the sample, the level of physical activity was unsatisfactory, and 70% had an accompanying risk factor for osteoporosis in addition to menopause. After 12 months of treatment, 100% compliance was recorded in 84% of the patients and significant reduction (p < 0.0001) of the bone mineral loss, regardless of the previous aminobisphosphonate treatment. The treatment was tolerated well, with no serious adverse reactions. Some, mainly gastrointestinal complaints, registered in the first month (6%), were significantly relieved (p < 0.0001) after 12 months of treatment (1%). CONCLUSION Ibandronate manifested significant improvement of the BMD after 12 months of treatment of patients with decreased BMD, with good tolerance and excellent treatment compliance.