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Effectiveness of Calcifediol in Improving Muscle Function in Post-Menopausal Women: A Prospective Cohort Study

Abstract

Introduction

The role of vitamin D supplementation on muscle function and physical performance is still debated. Calcifediol is an available treatment for hypovitaminosis D, particularly for extra-skeletal effects. Aim of this prospective cohort study was to evaluate the effectiveness of calcifediol on serum levels of 25(OH)D3, appendicular muscle strength, physical performance, and prevention of falls in post-menopausal women.

Methods

We recruited post-menopausal women aged ≥50 years, referring to an outpatient service for the management of osteoporosis over a 18-month period. We included women with a diagnosis of osteoporosis and/or vitamin D deficiency [serum levels of 25(OH)D3 <30 ng/ml]. All the participants received calcifediol (20 μg, 4 oral drops/day) for a 6-month period. We evaluated at the baseline and after 6 months the following outcomes: serum levels of 25(OH)D3, appendicular muscle strength, using the Isometric Hand Grip Strength Test and the Knee Isometric Extension Strength Test, physical performance, using the Short Physical Performance Battery (SPPB) and the 4-m gait speed (4MGS), and the risk of falls (percentage of fallers and recurrent fallers and mean number of falls). A sub-analysis was performed in patients with vitamin D deficiency.

Results

We enrolled 113 post-menopausal women, mean aged 68.01 ± 9.13 years. After 6 months of treatment, there was a significant increase in serum levels of 25(OH)D3 (p < 0.001), appendicular muscle strength (p < 0.001), and physical performance (p = 0.002 at SPPB and p = 0.010 at 4MGS, respectively). At 6 months, the percentage of fallers was lower, although not significantly (p = 0.078), whereas there was a significant reduction both in percentage of recurrent fallers and in the mean number of falls (p < 0.001 and p = 0.020, respectively).

Conclusion

Calcifediol was significantly effective in improving serum levels of 25(OH)D3 and muscle function and in reducing the percentage of recurrent fallers and the mean number of falls in a cohort of post-menopausal women.

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Acknowledgements

No funding or sponsorship was received for this study or publication of this article.

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Disclosures

Giovanni Iolascon, Antimo Moretti, Alessandro de Sire, Dario Calafiore, and Francesca Gimigliano have no disclosures for any personal, financial, commercial, or academic conflicts of interest separately.

Compliance with Ethics Guidelines

This cohort study respects the Declaration of Helsinki and all the criteria of a prospective study of real practice, approved by the Ethical Committee of University of Campania “Luigi Vanvitelli”. All the participants were asked to carefully read and sign an informed consent, and researchers provided to protect the participants’ privacy.

Data Availability

The dataset of the current study is available from the corresponding author on reasonable request.

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Correspondence to Giovanni Iolascon.

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Iolascon, G., Moretti, A., de Sire, A. et al. Effectiveness of Calcifediol in Improving Muscle Function in Post-Menopausal Women: A Prospective Cohort Study. Adv Ther 34, 744–752 (2017). https://doi.org/10.1007/s12325-017-0492-0

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Keywords

  • Calcifediol
  • Falls
  • Muscle strength
  • Orthopedics
  • Physical performance
  • Sarcopenia
  • Vitamin D
  • Vitamin D deficiency