The non-interventional BonViva Intravenous Versus Alendronate (VIVA) study: Real-world adherence and persistence to medication, efficacy, and safety, in patients with postmenopausal osteoporosis

摘要

Adherence and persistence to oral bisphosphonates in women with postmenopausal osteoporosis is suboptimal. In this study, patients were treated with either oral or intravenous bisphosphonates. The increased adherence and persistence observed in patients receiving intravenous medication compared with those receiving oral medication may improve health outcomes. Introduction: Poor adherence and persistence to oral medication are often observed in women with postmenopausal osteoporosis (PMO). The purpose of the non-interventional BonViva Intravenous Versus Alendronate (VIVA) study was to determine whether, in a real-world setting, (1) increased adherence and persistence to medication would be observed in women with PMO receiving intravenous (i.v.) ibandronate versus oral alendronate, (2) a correlation exists between adherence and persistence to medication and drug efficacy, and (3) any unexpected adverse events/serious adverse events (AEs/SAEs) may occur. Methods: The study was conducted in 632 centers in Germany. A total of 6,064 females with PMO were enrolled and recruited into one of two treatment arms: quarterly i.v. administration of 3 mg ibandronate or weekly oral medication of 70 mg alendronate, for 12 months. At the end of the study, adherence and persistence to medication, new osteoporotic fractures, mobility, use of analgesics, and AEs/SAEs were determined. Results: Greater adherence and persistence to medication were observed in the ibandronate treatment arm compared with the alendronate treatment arm. Although there was no significant difference in the number of patients with new vertebral, hip, or forearm fractures between treatment arms, a significantly greater increase in mobility and decrease in the use of analgesics were reported in the ibandronate treatment arm. No unexpected AEs/SAEs occurred in either arm. Conclusions: Adherence and persistence to medication were greater in women with PMO receiving i.v. ibandronate compared with those receiving oral alendronate. This may have led to an increase in mobility and a decrease in pain in these patients.