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

ABSTRACT

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.