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Increases in Hip and Spine Bone Mineral Density are Predictive for Vertebral Antifracture Efficacy with Ibandronate

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Abstract

The relationship between bisphosphonate-induced bone mineral density (BMD) gains and antifracture efficacy remains to be fully elucidated. Data from two antifracture studies were analyzed. Postmenopausal osteoporotic women received oral (2.5 mg daily, 20 mg intermittent) or intravenous (0.5 mg, 1 mg quarterly) ibandronate. Outcome measures included moving averages plots and logistic regression analyses of the relationship between BMD change and vertebral fracture rate. In moving averages plots, ibandronate-induced BMD gains were consistently associated with decreased fracture rates. In the oral study, total-hip BMD increases at years 2 and 3 and lumbar spine BMD increases at year 3 were associated with 3-year vertebral fracture rate (relative risk reduction [RRR] at year 3 for 1% change from baseline: hip, 7.9% [95% CI 2.1–13.5%, P = 0.0084]; lumbar spine, 4.7% [−0.1% to 9.3%, P = 0.0565]). In the intravenous study, total-hip BMD increases at years 1, 2, and 3 and lumbar spine BMD increases at years 2 and 3 were significantly associated with vertebral fracture rate (RRR at year 3 for 1% change from baseline: hip, 11.6% [7.0–16.0%, P < 0.0001]; lumbar spine, 6.9% [2.9–10.6%, P = 0.0008]). In a pooled analysis, changes in total-hip and lumbar spine BMD were associated with 3-year vertebral fracture risk reduction and explained a substantial proportion of the antifracture effect (23–37% at 2 and 3 years). This analysis suggests that ibandronate-induced BMD gain in postmenopausal osteoporotic women is associated with vertebral fracture risk reduction.

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Acknowledgments

We dedicate this work to Professor Delmas, who sadly passed away during the preparation of this manuscript. We are indebted to all those who have contributed to the conduct and analysis of the BONE and IV ibandronate studies. We also acknowledge medical writing assistance provided by Charlotte Kennerley, Catherine Lee, and Louise Profit (Gardiner-Caldwell Communications) in the preparation of this manuscript, funding for which was provided by F. Hoffmann-La Roche.

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Authors and Affiliations

  1. Colorado Center for Bone Research, 3190 South Wadsworth Boulevard, Lakewood, CO, 80227, USA

    Paul D. Miller

  2. INSERM Research Unit 831 and University of Lyon, Lyon, France

    Pierre D. Delmas

  3. Bayer Vital GmbH, Kaiser-Wilhelm-Allee 1, 51373, Leverkusen, Germany

    Hermann Huss

  4. Roche Products, Welwyn Garden City, UK

    Katie M. Patel

  5. F. Hoffmann-La Roche, Basel, Switzerland

    Ralph C. Schimmer

  6. University of Verona, Verona, Italy

    Silvano Adami

  7. Osteoporosis Research Center, Creighton University, Omaha, NE, USA

    Robert R. Recker

Authors
  1. Paul D. Miller
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  2. Pierre D. Delmas
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  3. Hermann Huss
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  4. Katie M. Patel
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  5. Ralph C. Schimmer
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  6. Silvano Adami
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Correspondence to Paul D. Miller.

Additional information

P. D. and S. A. have received consultant and speaker fees as well as a research grant from Roche; P. M. and R. R. are consultants and members of Roche advisory boards and invited speakers for Roche; K. P. is an employee of Roche Products, Ltd., and R. S. is an employee of F. Hoffmann-La Roche, Ltd.; at the time of the analysis included in this report H. H. was an employee of F. Hoffmann-La Roche, Ltd.

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Miller, P.D., Delmas, P.D., Huss, H. et al. Increases in Hip and Spine Bone Mineral Density are Predictive for Vertebral Antifracture Efficacy with Ibandronate. Calcif Tissue Int 87, 305–313 (2010). https://doi.org/10.1007/s00223-010-9403-y

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