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Impact of clinical fractures on health-related quality of life is dependent on time of assessment since fracture: results from the FREEDOM trial

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Abstract

Summary

In the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study, women with incident clinical fractures reported significant declines in health-related quality of life (HRQoL). The largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain.

Introduction

In the FREEDOM trial, denosumab significantly reduced the risk of new vertebral, hip, and nonvertebral fractures. We evaluated the effect of denosumab on HRQoL and the association between incident clinical fractures and HRQoL.

Methods

The FREEDOM trial enrolled 7,868 women aged 60–90 years with a total hip and/or lumbar spine BMD T-score <−2.5 and not <−4.0 at either site. Women were randomized to receive denosumab 60 mg or placebo every 6 months, in addition to daily calcium and vitamin D. HRQoL was assessed with the Osteoporosis Assessment Questionnaire-Short Version (OPAQ-SV) at baseline and every 6 months for 36 months. The OPAQ-SV assesses physical function, emotional status, and back pain. Higher scores indicate better health status.

Results

No statistically significant differences in mean change in HRQoL from baseline to end of study were found when comparing treatment groups. Compared with women without any incident fractures during the study, women with incident clinical fractures reported significant declines in physical function (−4.0 vs. −0.5) and emotional status (−5.0 vs. −0.8) at month 36 (P < 0.001 for both). Importantly, time-dependent covariate analyses demonstrated that the largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain.

Conclusions

These findings not only demonstrate that incident clinical fractures impact HRQoL but also contribute new information regarding the impact of these fracture events on HRQoL over time.

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Acknowledgments

Amgen Inc. sponsored this study. The authors would like to thank Michelle Geller, MD; Andreas Grauer, MD; Luanda Grazette, MD; and Cesar Libanati, MD, for their contribution toward the development of the comorbidity index, and Michelle N. Bradley, PhD, who provided medical writing support on behalf of Amgen Inc.

Conflicts of interest

This study was funded by Amgen Inc. S. Silverman is a consultant, speaker, and/or research investigator for Amgen Inc., Eli Lilly, Merck, Novartis, Procter & Gamble, Roche Diagnostics, Roche Pharmaceuticals, and Wyeth. H. N. Viswanathan, Y-C Yang, A. Wang, and D. Macarios are employees and shareholders of Amgen Inc. S. Boonen is a consultant for Amgen Inc. S. Ragi-Eis is a consultant, advisory board member, speaker, and/or research investigator for Amgen Inc., Merck, Novartis, Pfizer, Roche, and Sanofi–Aventis. P. Fardellone, N. Gilchrist, S. Palacios, and K. Pavelka are investigators for Amgen Inc. P. Lips is a speaker and/or research investigator for Amgen Inc., Eli Lilly, Merck, Servier, and Wyeth. M. Nevitt and D. Revicki are consultants and investigators for Amgen Inc. J. Simon is a consultant, advisory board member, speaker, and/or research investigator for Allergan, The Alliance for Better Bone Health, Amgen Inc., Ascend Therapeutics, Barr, Bayer, BioSante, Boehringer Ingelheim, Corcept Therapeutics, FemmePharma, GSK, KV Pharmaceutical, Meditrina Pharmaceuticals, Merck, Merrion Pharmaceuticals, Nanma/Tripharma/Trinity, Novartis, Novo Nordisk, Novogyne, Pear Tree Pharmaceuticals, Procter & Gamble, QuatRx Pharmaceuticals, Roche, Schering-Plough, Sciele, Solvay, Warner Chilcott, and Wyeth. E. Siris is a consultant, advisory board member, and/or speaker for Amgen, Eli Lilly, Merck, Novartis, and Pfizer.

Author information

Authors and Affiliations

  1. Cedars-Sinai/UCLA and OMC Clinical Research Center, 8641 Wilshire Boulevard, Suite 301, Beverly Hills, CA, 90211, USA

    S. Silverman

  2. Amgen Inc, Thousand Oaks, CA, USA

    H. N. Viswanathan, Y.-C. Yang, A. Wang & D. Macarios

  3. Leuven University, Leuven, Belgium

    S. Boonen

  4. CEDOES Diagnóstico e Pesquisa, Vitória, ES, Brazil

    S. Ragi-Eis

  5. CHU Amiens, INSERM ERI 12, Amiens, France

    P. Fardellone

  6. CGM Research Trust and Canterbury District Health Board, Christchurch, New Zealand

    N. Gilchrist

  7. VU University Medical Center, Amsterdam, The Netherlands

    P. Lips

  8. University of California San Francisco, San Francisco, CA, USA

    M. Nevitt

  9. Palacios Institute of Woman’s Health, Madrid, Spain

    S. Palacios Gil-Antuñano

  10. Charles University, Prague, Czech Republic

    K. Pavelka

  11. United BioSource Corporation, Bethesda, MD, USA

    D. Revicki

  12. Women’s Health & Research Consultants®, Washington, DC, USA

    J. Simon

  13. Columbia University Medical Center, New York, NY, USA

    E. S. Siris

Authors
  1. S. Silverman
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  2. H. N. Viswanathan
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  3. Y.-C. Yang
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  4. A. Wang
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  5. S. Boonen
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  6. S. Ragi-Eis
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  7. P. Fardellone
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  8. N. Gilchrist
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  9. P. Lips
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  10. M. Nevitt
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  11. S. Palacios Gil-Antuñano
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  12. K. Pavelka
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  13. D. Revicki
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  14. J. Simon
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  15. D. Macarios
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  16. E. S. Siris
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Corresponding author

Correspondence to S. Silverman.

Additional information

Clinicaltrials.gov

NCT00089791; August 13, 2004

Financial support

This study was sponsored by Amgen Inc., Thousand Oaks, CA, USA.

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Silverman, S., Viswanathan, H.N., Yang, YC. et al. Impact of clinical fractures on health-related quality of life is dependent on time of assessment since fracture: results from the FREEDOM trial. Osteoporos Int 23, 1361–1369 (2012). https://doi.org/10.1007/s00198-011-1720-0

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  • DOI: https://doi.org/10.1007/s00198-011-1720-0

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