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Clinical Trial
. 2019 Sep;177(2):427-435.
doi: 10.1007/s10549-019-05319-4. Epub 2019 Jun 19.

Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia

Polly Niravath  1 , Susan G Hilsenbeck  2 , Tao Wang  2 , Sao Jiralerspong  2 , Julie Nangia  2 , Anne Pavlick  2 , Foluso Ademuyiwa  3 , Ashley Frith  3 , Cynthia Ma  3 , Haeseong Park  3 , Caron Rigden  3 , Rama Suresh  3 , Matthew Ellis  2 , C Kent Osborne  2 , Mothaffar F Rimawi  2
Affiliations
Clinical Trial

Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia

Polly Niravath et al. Breast Cancer Res Treat. 2019 Sep.

Abstract

Purpose: Half of hormone receptor-positive (HR+) breast cancer patients will develop joint pain, termed aromatase inhibitor-induced arthralgia (AIA), while taking aromatase inhibitor therapy. Though there is no universally accepted effective treatment for AIA, there has been some evidence to support high-dose vitamin D as a treatment.

Methods: We randomized post-menopausal women who were beginning adjuvant AI therapy to receive standard-dose vitamin D3 (800 IU daily for 52 weeks), or high-dose vitamin D3 (50,000 IU weekly for 12 weeks, followed by 2000 IU daily for 40 weeks). The primary end point was development of AIA. The trial was designed to enroll 184 patients. This futility analysis was performed after 93 patients were enrolled.

Results: The high-dose vitamin D regimen was effective in raising serum vitamin D levels, but there was no significant difference in development of AIA between the two arms. In the high-dose arm, 25 patients (54%) developed AIA, compared to 27 patients (57%) in the standard-dose arm. The planned futility analysis was positive; thus, the study was terminated. Neither baseline vitamin D nor 12-week vitamin D level was predictive of AIA development.

Conclusion: Although vitamin D levels were increased in the high-dose arm, there was no significant signal for benefit of high-dose vitamin D supplementation for AIA prevention in this unblinded trial. This study, along with several others, implies that vitamin D likely does not play a significant role in AIA for the majority of patients.

Keywords: Aromatase inhibitor-induced arthralgia; Cancer survivorship; Medication compliance; Vitamin D.

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References

    1. Rimawi M, Osborne C (2010) Adjuvant systemic therapy: endocrine therapy. In: Harris J, Morrow M, Lippman M, Osborne C (eds) Diseases of the breast, 4th edn. Lippincoot Williams & Wilkins, Philadelphia, Pennsylvania, pp 610–630
    1. Mouridsen H, Giobbie-Hurder A, Goldhirsch A (2009) Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med 361(8):766–776 - DOI - PubMed
    1. Howell A, Cuzick J, Baum M et al (2005) Results of the ATAC trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet 365:60–62 - DOI - PubMed
    1. Coombes R, Hall E, Gibson L, Paridaens R, Jassem J, Delozier T et al (2004) A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med 350(11):1081–1092 - DOI - PubMed
    1. Niravath P (2013) Aromatase inhibitor-induced arthalgia: a review. Ann Oncol 24(6):1443–1449 - DOI - PubMed

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