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

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Abstract

Summary

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.

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Acknowledgments

This study was funded by Roche Pharma AG, Grenzach-Wyhlen, Germany. The authors thank Dr. A. Defer, Dr. J. Pfeilschifter, and Dr. O. Gröschel for their participation in the study. The authors also thank Dr. M. Hoque from ACUMED for providing medical writing support, funded by Roche.

Conflicts of interest

Peyman Hadji: has received honoraria and research funding from Amgen, Roche, GlaxoSmithKline, Novartis, MSD, Daiichi Sankyo, Pfizer, Procter & Gamble, Eli Lilly, and Nycomed.

Lorenz Hofbauer receives honoraria for lectures and advisory board meetings from Amgen, Merck, and Novartis.

Dieter Felsenberg receives payment for consultancy/advisory boards from Amgen, Chugai Pharmaceutical Co. Ltd., GlaxoSmithKline, Lilly, MSD, Novartis, Nycomed, Roche, Servier, and Teva Pharmaceutical Industries Ltd.; lecture fees from Amgen, Chugai, GE Healthcare, GlaxoSmithKline, Lilly, MSD, Novartis, Nycomed, Roche, Servier, Teva Pharmaceutical Industries Ltd., and Warner Chilcott; and grant support from Amgen, Chugai, Lilly, MSD, Novartis, Nycomed, Roche, Teva Pharmaceutical Industries Ltd., and Servier.

Andreas Kurth is a speaker for Roche and an active member on the advisory board for BonViva; is a speaker for Biomet, DFine Europe, Medtronic, Servier, Novartis, Lilly, Amgen, BMS, GlaxoSmithKline, Baxter, Boehringer Ingelheim, and Anwerina; and is a consultant for DFine Europe, Biomet, Servier, Amgen, Boehringer Ingelheim, and BMS.

Michael Amling is a consultant and speaker for Roche, Novartis, Procter and Gamble, MSD, Servier, and Lilly. No royalties were received.

Julia Annabel Kandenwein is an employee of Roche Pharma Germany.

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Authors and Affiliations

  1. Department of Gynaecological Endocrinology, Reproductive Medicine, and Osteoporosis, Philipps-University of Marburg, Baldingerstrasse, 35033, Marburg, Germany

    P. Hadji

  2. Hochschulambulanz Osteologie & Muskel, Zentrum für Muskel- & Knochenforschung, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Freie Universität & Humboldt-Universität Berlin, 12203, Berlin, Germany

    D. Felsenberg

  3. Department of Osteology and Biomechanics, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20251, Hamburg, Germany

    M. Amling

  4. Division of Endocrinology, Diabetes, and Bone Diseases, Dresden Technical University Medical Center, Fetscherstrasse 74, 01307, Dresden, Germany

    L. C. Hofbauer

  5. Roche Pharma AG, Emil-Barell-Strasse 1, 79639, Grenzach, Germany

    J. A. Kandenwein

  6. Weidmannstr. 61, 55131, Mainz, Germany

    A. Kurth

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  1. P. Hadji
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  2. D. Felsenberg
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  3. M. Amling
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Correspondence to P. Hadji.

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Hadji, P., Felsenberg, D., Amling, M. et al. The non-interventional BonViva Intravenous Versus Alendronate (VIVA) study: real-world adherence and persistence to medication, efficacy, and safety, in patients with postmenopausal osteoporosis. Osteoporos Int 25, 339–347 (2014). https://doi.org/10.1007/s00198-013-2515-2

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  • DOI: https://doi.org/10.1007/s00198-013-2515-2

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