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This article has a correction

Please see: Ann Rheum Dis 2008;67:280

Ann Rheum Dis 65:654-661 doi:10.1136/ard.2005.044958
  • Extended report

Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study

  1. J-Y Reginster1,
  2. S Adami2,
  3. P Lakatos3,
  4. M Greenwald4,
  5. J J Stepan5,
  6. S L Silverman6,
  7. C Christiansen7,
  8. L Rowell8,
  9. N Mairon8,
  10. B Bonvoisin8,
  11. M K Drezner9,
  12. R Emkey10,
  13. D Felsenberg11,
  14. C Cooper12,
  15. P D Delmas13,
  16. P D Miller14
  1. 1University of Liège, Liège, Belgium
  2. 2University of Verona, Verona, Italy
  3. 3Semmelweis University Medical School, Budapest, Hungary
  4. 4Desert Medical Advances, Palm Desert, CA, USA
  5. 5Charles University School of Medicine, Prague, Czech Republic
  6. 6Cedars Sinai Medical Center, Los Angeles, CA, USA
  7. 7Centre for Clinical and Basic Research, Ballerup, Denmark
  8. 8F Hoffmann-La Roche Ltd, Basel, Switzerland
  9. 9University of Wisconsin, Madison, WI, USA
  10. 10Radiant Research, Wyomissing, PA, USA
  11. 11Charité-University Medicine Berlin, Campus Benjamin Franklin, Free University and Humboldt-University, Berlin, Germany
  12. 12MRC Epidemiology Resource Centre, University of Southampton, Southampton, UK
  13. 13Claude Bernard University and INSERM Research Unit 403, Lyon, France
  14. 14Colorado Center for Bone Research, Lakewood, CO, USA
  1. Correspondence to:
    Professor J-Y Reginster
    Unité d’Exploration du Metabolisme de l’Os et du Cartilage, CHU Centre Ville, Liège, Belgium; jyreginster{at}ulg.ac.be
  • Accepted 27 November 2005
  • Published Online First 8 December 2005

Abstract

Background: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem.

Objective: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis.

Methods: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo.

Results: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5–93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups.

Conclusions: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes.

Footnotes

  • Published Online First 5 January 2006

  • Competing interests: The authors have received fees or reimbursement from the study sponsors, F Hoffmann-La Roche Ltd and GlaxoSmithKline, for the following activities/items: consulting: J-YR, SA, MG, SLS, CCh, MKD, CCo, DF, PDD, PDM; research grants: J-YR, MG, SLS, MKD, DF, PDM; attending symposia: J-YR, SA, JJS, MKD, CCo, DF, PDD; giving lectures: J-YR, SA, MG, SLS, MKD, RE, CCo, DF, PDD; funds for a member of staff: JJS; organising educational programmes: DF. LR, NM, BB are employees of Hoffmann-La Roche Ltd. PL has no competing interests.