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VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men

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Abstract

Summary

We investigated the association of clinical variables with TBS at baseline in the bone health sub-cohort of the VITamin D and OmegA-3 TriaL (VITAL). Lower TBS was associated with female sex, aging, BMI ≥ 25 kg/m2, SSRI use, high alcohol intake, and presence of diabetes; there was a trend towards significance between lower TBS and history of fragility fractures.

Introduction

We investigated whether TBS differs by sex, race, body mass index (BMI), and other clinical variables.

Methods

The VITamin D and OmegA-3 TriaL (VITAL) is determining effects of vitamin D3 and/or omega-3 fatty acid (FA) supplements in reducing risks of cancer and cardiovascular disease. In the VITAL: Effects on Bone Structure/Architecture ancillary study, effects of these interventions on bone will be investigated. Here, we examine the associations of clinical risk factors with TBS assessments at baseline in the bone health sub-cohort, comprised of 672 participants (369 men and 303 women), mean (± SD) age 63.5 ± 6.0 years; BMI ≤ 37 kg/m2, no bisphosphonates within 2 years or other bone active medications within 1 year.

Results

TBS was greater in men than women (1.311 vs. 1.278, P < 0.001) and lower with elevated BMIs (P < 0.001), higher age (P = 0.004), diabetes (P = 0.008), SSRI use (P = 0.044), and high alcohol intake (P = 0.009). There was a trend for history of fragility fractures (P = 0.072), and lower TBS. TBS did not vary when analyzed by race, smoking, history of falls, and multivitamin or caffeine use.

Conclusions

Lower TBS was associated with female sex, aging, BMI ≥ 25 kg/m2, SSRI use, alcohol use, and presence of diabetes; there was a trend between lower TBS and history of fragility fractures. TBS may be useful clinically to assess structural changes that may be associated with fractures among patients who are overweight or obese, those on SSRIs, or with diabetes. Ongoing follow-up studies will clarify the effects of supplemental vitamin D3 and/or FA’s on TBS and other bone health measures.

Trial registration

NCT01747447

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Acknowledgments

Members of the VITAL Data and Safety Monitoring Board include Lawrence S. Cohen, Theodore Colton, Mark A. Espeland, I. Craig Henderson, Alice H. Lichtenstein, Rebecca A. Silliman, and Nanette K. Wenger (chair), and Josephine Boyington, Cindy D. Davis, Rebecca B. Costello, Gabriela Riscuta, Harold Seifried, Lawrence Fine, and Peter Greenwald (ex-officio members). We would also like to acknowledge Vadim Bubes and Gregory Kotler, the data analysts for this project. We would also like to acknowledge the contribution of the Steve Cobb Junior Faculty Education Fund. In addition, we would like to acknowledge Andrea Alvarez, a summer research student from Winsor High School, for her contributions to this research.

Grants

Research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Numbers R01AR59775 (LeBoff, M.S., PI) and R01AR060574 (LeBoff, M.S., PI), respectively. The parent VITAL trial is supported by grant U01CA138962 (Manson, J. and Buring, J, PIs). Support for this research was also provided from the Harvard Catalyst Clinical and Translational Science Center (CTSC) (NIH Award UL1 TR001102) and the Steve Cobb Junior Faculty and Fellow Education Fund. Pharmavite LLC of Northridge, California (vitamin D) and Pronova BioPharma (BASF) of Norway (Omacor® fish oil) donated the study agents, matching placebos, and packaging in the form of calendar packs.

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Authors and Affiliations

  1. Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, 02115, USA

    A. L. Goldman, C. M. Donlon, C. Y. Yu & M. S. LeBoff

  2. Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, 02115, USA

    N. R. Cook, J. E. Manson, J. E. Buring & T. Copeland

  3. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, 02115, USA

    N. R. Cook, J. E. Manson & J. E. Buring

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  1. A. L. Goldman
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  2. C. M. Donlon
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  4. J. E. Manson
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  7. C. Y. Yu
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  8. M. S. LeBoff
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Corresponding author

Correspondence to M. S. LeBoff.

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Appendix

Appendix

Table 4 Baseline characteristics of the VITAL CTSC TBS sub-cohort, according to sex and adjusted for age, race (Black vs non-Black), and BMI
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Goldman, A.L., Donlon, C.M., Cook, N.R. et al. VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men. Osteoporos Int 29, 2505–2515 (2018). https://doi.org/10.1007/s00198-018-4633-3

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