Osteoporosis International

, Volume 25, Issue 1, pp 339–347 | Cite as

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

  • P. Hadji
  • D. Felsenberg
  • M. Amling
  • L. C. Hofbauer
  • J. A. Kandenwein
  • A. Kurth
Original Article

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.

Keywords

Adherence Alendronate Ibandronate Intravenous Persistence Postmenopausal osteoporosis 

References

  1. 1.
    National Osteoporosis Foundation (2003) Physician’s guide to prevention and treatment of osteoporosis. Excerpta Medica, Belle MeadGoogle Scholar
  2. 2.
    Sambrook P, Cooper C (2006) Osteoporosis. Lancet 367:2010–2018PubMedCrossRefGoogle Scholar
  3. 3.
    Hadji P, Klein S, Gothe H, Häussler B, Kless T, Schmidt T, Steinle T, Verheyen F, Linder R (2013) The epidemiology of osteoporosis—Bone Evaluation Study (BEST): an analysis of routine health insurance data. Dtsch Arztebl Int 110:52–57PubMedCentralPubMedGoogle Scholar
  4. 4.
    Ström O, Borgström F, Kanis JA, Compston J, Cooper C, McCloskey EV, Jönsson B (2012) Osteoporosis: burden, health care provision and opportunities in the EU: a report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 6:59–155CrossRefGoogle Scholar
  5. 5.
    Hooven FH, Adachi JD, Adami S, Boonen S, Compston J, Cooper C, Delmas P, Diez-Perez A, Gehlbach S, Greenspan SL, LaCroix A, Lindsay R, Netelenbos JC, Pfeilschifter J, Roux C, Saag KG, Sambrook P, Silverman S, Siris E, Watts NB, Anderson FA Jr (2009) The Global Longitudinal Study of Osteoporosis in Women (GLOW): rationale and study design. Osteoporos Int 20:1107–1116PubMedCentralPubMedCrossRefGoogle Scholar
  6. 6.
    Prieto-Alhambra D, Nogues X, Javaid MK, Wyman A, Arden NK, Azagra R, Cooper C, Adachi JD, Boonen S, Chapurlat RD, Compston JE, Gehlbach SH, Greenspan SL, Hooven FH, Netelenbos JC, Pfeilschifter J, Rossini M, Sambrook PN, Silverman S, Siris ES, Watts NB, Díez-Pérez A (2013) An increased rate of falling leads to a rise in fracture risk in postmenopausal women with self-reported osteoarthritis: a prospective multinational cohort study (GLOW). Ann Rheum Dis 72(6):911–7PubMedCrossRefGoogle Scholar
  7. 7.
    Rizzoli R (2011) Bisphosphonates for post-menopausal osteoporosis: are they all the same? QJM 104:281–300PubMedCrossRefGoogle Scholar
  8. 8.
    Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541PubMedCrossRefGoogle Scholar
  9. 9.
    Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH 3rd, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352PubMedCrossRefGoogle Scholar
  10. 10.
    Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J, ABC Project Team (2012) A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol 73:691–705PubMedCrossRefGoogle Scholar
  11. 11.
    Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C (2004) The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 15:1003–1008PubMedCrossRefGoogle Scholar
  12. 12.
    Höer A, Seidlitz C, Gothe H, Schiffhorst G, Olson M, Hadji P, Häussler B (2009) Influence on persistence and adherence with oral bisphosphonates on fracture rates in osteoporosis. Patient Prefer Adherence 3:25–30PubMedCentralPubMedGoogle Scholar
  13. 13.
    Penning-van Beest FJ, Erkens JA, Olson M, Herings RM (2008) Loss of treatment benefit due to low compliance with bisphosphonate therapy. Osteoporos Int 19:511–517PubMedCentralPubMedCrossRefGoogle Scholar
  14. 14.
    Siris ES, Selby PL, Saag KG, Borgström F, Herings RM, Silverman SL (2009) Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 122(2 Suppl):S3–S13PubMedCrossRefGoogle Scholar
  15. 15.
    Silverman SL, Schousboe JT, Gold DT (2011) Oral bisphosphonate compliance and persistence: a matter of choice? Osteoporos Int 22:21–26PubMedCentralPubMedCrossRefGoogle Scholar
  16. 16.
    Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262PubMedGoogle Scholar
  17. 17.
    Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B (2003) Early discontinuation of treatment for osteoporosis. Am J Med 115:209–216PubMedCrossRefGoogle Scholar
  18. 18.
    Simon JA, Lewiecki EM, Smith ME, Petruschke RA, Wang L, Palmisano JJ (2002) Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study. Clin Ther 24:1871–1886PubMedCrossRefGoogle Scholar
  19. 19.
    Thiébaud D, Burckhardt P, Kriegbaum H, Huss H, Mulder H, Juttmann JR, Schöter KH (1997) Three monthly intravenous injections of ibandronate in the treatment of postmenopausal osteoporosis. Am J Med 103:298–307PubMedCrossRefGoogle Scholar
  20. 20.
    Adami S, Felsenberg D, Christiansen C, Robinson J, Lorenc RS, Mahoney P, Coutant K, Schimmer RC, Delmas PD (2004) Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 34:881–889PubMedCrossRefGoogle Scholar
  21. 21.
    Delmas PD, Adami S, Strugala C, Stakkestad JA, Reginster JY, Felsenberg D, Christiansen C, Civitelli R, Drezner MK, Recker RR, Bolognese M, Hughes C, Masanauskaite D, Ward P, Sambrook P, Reid DM (2006) Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study. Arthritis Rheum 54:1838–1846PubMedCrossRefGoogle Scholar
  22. 22.
    Eisman JA, Civitelli R, Adami S, Czerwinski E, Recknor C, Prince R, Reginster JY, Zaidi M, Felsenberg D, Hughes C, Mairon N, Masanauskaite D, Reid DM, Delmas PD, Recker RR (2008) Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. J Rheumatol 35:488–497PubMedGoogle Scholar
  23. 23.
    Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D (2012) Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int 23:1769–1778PubMedCrossRefGoogle Scholar
  24. 24.
    Feldstein AC, Weycker D, Nichols GA, Oster G, Rosales G, Boardman DL, Perrin N (2009) Effectiveness of bisphosphonate therapy in a community setting. Bone 44:153–159PubMedCrossRefGoogle Scholar
  25. 25.
    Barrett-Connor E, Wade SW, Do TP, Satram-Hoang S, Stewart R, Gao G, Macarios D (2012) Treatment satisfaction and persistence among postmenopausal women on osteoporosis medications: 12-month results from POSSIBLE US™. Osteoporos Int 23:733–741PubMedCrossRefGoogle Scholar
  26. 26.
    Hadji P, Minne H, Pfeifer M, Bourgeois P, Fardellone P, Licata A, Devas V, Masanauskaite D, Barrett-Connor E (2008) Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: a randomized, crossover study (BALTO II). Joint Bone Spine 75:303–310PubMedCrossRefGoogle Scholar
  27. 27.
    Silverman S, Gold DT (2010) Compliance and persistence with osteoporosis medications: a critical review of the literature. Rev Endocr Metab Disord 11:275–280PubMedCentralPubMedCrossRefGoogle Scholar
  28. 28.
    Gold DT, Martin BC, Frytak JR, Amonkar MM, Cosman F (2007) A claims database analysis of persistence with alendronate therapy and fracture risk in post-menopausal women with osteoporosis. Curr Med Res Opin 23:585–594PubMedCrossRefGoogle Scholar
  29. 29.
    Hadji P, Claus V, Ziller V, Intorcia M, Kostev K, Steinle T (2012) GRAND: the German retrospective cohort analysis on compliance and persistence and the associated risk of fractures in osteoporotic women treated with oral bisphosphonates. Osteoporos Int 23:223–231PubMedCrossRefGoogle Scholar
  30. 30.
    Ziller V, Kostev K, Kyvernitakis I, Boeckhoff J, Hadji P (2012) Persistence and compliance of medications used in the treatment of osteoporosis-analysis using a large-scale, representative, longitudinal German database. Int J Clin Pharmacol Ther 50:315–322PubMedCrossRefGoogle Scholar
  31. 31.
    Seeman E, Compston J, Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, Jönsson B, Pols H, Cramer JA (2007) Non-compliance: the Achilles’ heel of anti-fracture efficacy. Osteoporos Int 18:711–719PubMedCrossRefGoogle Scholar
  32. 32.
    Sarrel PM (1999) Improving adherence to hormone replacement therapy with effective patient-physician communication. Am J Obstet Gynecol 180:S337–S340PubMedCrossRefGoogle Scholar
  33. 33.
    Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, Freedholm D (2000) Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial. Arch Intern Med 160:517–525PubMedCrossRefGoogle Scholar
  34. 34.
    Greenspan S, Field-Munves E, Tonino R, Smith M, Petruschke R, Wang L, Yates J, de Papp AE, Palmisano J (2002) Tolerability of once-weekly alendronate in patients with osteoporosis: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc 77:1044–1052PubMedCrossRefGoogle Scholar
  35. 35.
    Eisman JA, Rizzoli R, Roman-Ivorra J, Lipschitz S, Verbruggen N, Gaines KA, Melton ME (2004) Upper gastrointestinal and overall tolerability of alendronate once weekly in patients with osteoporosis: results of a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 20:699–705PubMedCrossRefGoogle Scholar
  36. 36.
    Dennison EM, Compston JE, Flahive J, Siris ES, Gehlbach SH, Adachi JD, Boonen S, Chapurlat R, Díez-Pérez A, Anderson FA Jr, Hooven FH, LaCroix AZ, Lindsay R, Netelenbos JC, Pfeilschifter J, Rossini M, Roux C, Saag KG, Sambrook P, Silverman S, Watts NB, Greenspan SL, Premaor M, Cooper C, Investigators GLOW (2012) Effect of co-morbidities on fracture risk: findings from the Global Longitudinal Study of Osteoporosis in Women (GLOW). Bone 50:1288–1293PubMedCrossRefGoogle Scholar
  37. 37.
    Curtis JR, Xi J, Westfall AO, Cheng H, Lyles K, Saag KG, Delzell E (2009) Improving the prediction of medication compliance: the example of bisphosphonates for osteoporosis. Med Care 47:334–341PubMedCentralPubMedCrossRefGoogle Scholar
  38. 38.
    Breuil V, Cortet B, Cotté FE, Arnould B, Dias-Barbosa C, Gaudin AF, Regnault A, Roborel de Climens A, Legrand E (2012) Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int 23:445–455PubMedCentralPubMedCrossRefGoogle Scholar
  39. 39.
    Häussler B, Gothe H, Göl D, Glaeske G, Pientka L, Felsenberg D (2007) Epidemiology, treatment and costs of osteoporosis in Germany—the BoneEVA Study. Osteoporos Int 18:77–84PubMedCrossRefGoogle Scholar
  40. 40.
    Huybrechts KF, Ishak KJ, Caro JJ (2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone 38:922–928PubMedCrossRefGoogle Scholar
  41. 41.
    Sunyecz JA, Mucha L, Baser O, Barr CE, Amonkar MM (2008) Impact of compliance and persistence with bisphosphonate therapy on health care costs and utilization. Osteoporos Int 19:1421–1429PubMedCrossRefGoogle Scholar

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2013

Authors and Affiliations

  • P. Hadji
    • 1
  • D. Felsenberg
    • 2
  • M. Amling
    • 3
  • L. C. Hofbauer
    • 4
  • J. A. Kandenwein
    • 5
  • A. Kurth
    • 6
  1. 1.Department of Gynaecological Endocrinology, Reproductive Medicine, and OsteoporosisPhilipps-University of MarburgBaldingerstrasseGermany
  2. 2.Hochschulambulanz Osteologie & Muskel, Zentrum für Muskel- & Knochenforschung, Charité - Universitätsmedizin Berlin, Campus Benjamin FranklinFreie Universität & Humboldt-Universität BerlinBerlinGermany
  3. 3.Department of Osteology and BiomechanicsUniversity Medical Center Hamburg-EppendorfHamburgGermany
  4. 4.Division of Endocrinology, Diabetes, and Bone DiseasesDresden Technical University Medical CenterDresdenGermany
  5. 5.Roche Pharma AGGrenzachGermany
  6. 6.MainzGermany

Personalised recommendations