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Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trials

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Abstract

Summary

In a cross-design synthesis, total fractures were similarly reduced by bisphosphonates among postmenopausal women in randomized trials (23.8%) and highly compliant/persistent patients in observational studies of large databases from routine practice (20.3%). Bisphosphonates also reduced nonvertebral, vertebral and hip fractures in randomized trials and observational studies. In the real-word setting, compliant/persistent patients can gain a benefit from bisphosphonates comparable to that of randomized trial participants.

Introduction

The purpose of the study was to determine whether clinical fracture risk reduction by bisphosphonate treatment in women with postmenopausal osteoporosis differs between randomized controlled trials and routine practice.

Methods

Randomized trials comparing bisphosphonate with placebo and observational studies comparing highly compliant/persistent with less compliant/persistent patients were sought by electronic searches and ancillary methods. Clinical fracture data were extracted from the study reports and quantitatively combined by random effects metaanalysis.

Results

The odds ratio (OR) for all clinical fractures in randomized trials of 0.762, with a 95% confidence interval (CI) of 0.680–0.855, was closely similar to that in the observational studies (OR, 0.797; CI, 0.748–0.850). Pooled clinical fracture reduction across both study designs was 22%. Nonvertebral, vertebral, and hip fractures were also significantly reduced by bisphosphonate treatment in both randomized trials and observational studies.

Conclusions

Compliant/persistent patients in the “real-world” setting benefit from bisphosphonate treatment to a similar extent as patients in randomized trials.

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Acknowledgment

This investigation was supported through an unrestricted grant from Novartis Pharmaceuticals Corp., East Hanover, NJ, USA.

Conflicts of interest

Drs. Wilkes and Navickis are stockholders of General Electric Co. Mr. Chan is an employee of Novartis Pharmaceuticals Corp. Dr. Lewiecki has received research grant support and/or served as a consultant, adviser, or lecturer for Amgen Inc., Eli Lilly and Co., GlaxoSmithKline plc, Merck & Co., Inc., Novartis Pharmaceuticals Corp., Pfizer Inc., Procter & Gamble, F. Hoffmann-La Roche Ltd, Sanofi-aventis, Les Laboratoires Servier, and Wyeth. He is a stockholder of General Electric Co., Procter & Gamble, and Teva Pharmaceutical Industries Ltd.

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Authors and Affiliations

  1. Hygeia Associates, 17988 Brewer Rd, Grass Valley, CA, 95949, USA

    M. M. Wilkes & R. J. Navickis

  2. Evidence Based Medicine, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA

    W. W. Chan

  3. New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA

    E. M. Lewiecki

Authors
  1. M. M. Wilkes
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  2. R. J. Navickis
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  3. W. W. Chan
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  4. E. M. Lewiecki
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Correspondence to M. M. Wilkes.

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Wilkes, M.M., Navickis, R.J., Chan, W.W. et al. Bisphosphonates and osteoporotic fractures: a cross-design synthesis of results among compliant/persistent postmenopausal women in clinical practice versus randomized controlled trials. Osteoporos Int 21, 679–688 (2010). https://doi.org/10.1007/s00198-009-0991-1

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  • DOI: https://doi.org/10.1007/s00198-009-0991-1

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