Randomized, blinded trial of vitamin D 3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)

Alice C. Shapiro, Susan A. Adlis, Kim Robien, Mark N. Kirstein, Shuang Liang, Sara A. Richter, Rachel E. Lerner

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

The purpose of the study was to evaluate the efficacy and safety of vitamin D 3 at 4000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D 3 . We conducted a single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stages I–IIIA breast cancer, taking AI and experiencing AIMSS [breast cancer prevention trial symptom scale-musculoskeletal (BCPT-MS) subscale ≥1.5] were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D 3 , then began the randomized assignment to either 600 IU D 3  (n = 56) or 4000 IU D 3  (n = 57) daily for 6 months. The primary endpoint was a change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general MS pain, joint pain, muscle stiffness, range for each question: 0 = not at all to 4 = extremely). Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events. We found no significant changes in AIMSS measures between women who took 4000 IU D 3 daily compared with 600 IU D 3 . The 4000 IU D 3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL).

Original languageEnglish (US)
Pages (from-to)501-512
Number of pages12
JournalBreast Cancer Research and Treatment
Volume155
Issue number3
DOIs
StatePublished - Feb 1 2016

Fingerprint

letrozole
Aromatase Inhibitors
Cholecalciferol
Pharmacokinetics
Hormones
Breast Neoplasms
Safety
Phase III Clinical Trials
Arthralgia
Random Allocation
Serum
Bone and Bones
Pain
Muscles
Health
Therapeutics
anastrozole

Keywords

  • Aromatase inhibitors
  • Arthralgias
  • Breast cancer
  • Vitamin D

Cite this

Randomized, blinded trial of vitamin D 3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) . / Shapiro, Alice C.; Adlis, Susan A.; Robien, Kim; Kirstein, Mark N.; Liang, Shuang; Richter, Sara A.; Lerner, Rachel E.

In: Breast Cancer Research and Treatment, Vol. 155, No. 3, 01.02.2016, p. 501-512.

Research output: Contribution to journalArticle

Shapiro, Alice C. ; Adlis, Susan A. ; Robien, Kim ; Kirstein, Mark N. ; Liang, Shuang ; Richter, Sara A. ; Lerner, Rachel E. / Randomized, blinded trial of vitamin D 3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) In: Breast Cancer Research and Treatment. 2016 ; Vol. 155, No. 3. pp. 501-512.
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