Efficacy and Safety of Once-Monthly Ibandronate Treatment in Patients with Low Bone Mineral Density – ESTHER Study: 24 Months of Follow-Up

Abstract

Introduction Osteoporosis is a major health and economic problem worldwide. The use of new drugs, such as ibandronate, is aimed at improving treatment of osteoporosis and currently poor compliance with BP therapy.

Objective To investigate efficacy and safety of ibandronate applied monthly, orally, in women with low bone mineral density (BMD).

Methods The prospective study was conducted in 34 centers in Serbia and included 77 women treated for 24 months with monthly ibandronate. The efficacy of treatment was assessed by change in bone mass values obtained by BMD measurement at the end of 24 months follow-up versus baseline and 12-months follow-up values. Compliance and safety, i.e. adverse effects (AE) were recorded.

Results Participants were postmenopausal (96%), osteoporotic (79.7%) females, diagnosed by lumbar spine DXA measurement (81%), with history of prior BP therapy in 33.8% women. The physical activity level significantly increased to the substantial level of activity (5.2% vs. 21.3%, p=0.003) during the study. After 12 and 24 months of treatment, BMD values significantly increased (p=0.002 and p<0.001). BP experienced patients improved more than BP naïve patients at both time points (p=0.012 and p=0.027, respectively). During the second 12 months of treatment the adherence was 96%; AE were recorded as mild gastrointestinal disturbances in 3.9%.

Conclusion Treatment by using ibandronate once monthly for 24 months was generally well tolerated and led to a significant increase in BMD in women with low BMD.

Keywords: osteoporosis; bone mineral density; bisphosphonates; ibandronat