The Women’s Health Initiative randomized trial of calcium plus vitamin D: Effects on breast cancer and arthralgias

R. T Chlebowski; K. C Johnson; C Kooperberg; A Hubbell; D Lane; M O’Sullivan; S Cummings; T Rohan; S Yasmeen; J Khandekar

doi:10.1200/jco.2006.24.18_suppl.lba6

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The Women’s Health Initiative randomized trial of calcium plus vitamin D: Effects on breast cancer and arthralgias

Journal article

Peer reviewed

The Women’s Health Initiative randomized trial of calcium plus vitamin D: Effects on breast cancer and arthralgias

R. T Chlebowski, K. C Johnson, C Kooperberg, A Hubbell, D Lane, M O’Sullivan, S Cummings, T Rohan, S Yasmeen and J Khandekar

Journal of clinical oncology, Vol.24(18_suppl), pp.LBA6-LBA6

2006-06-20

DOI: https://doi.org/10.1200/jco.2006.24.18_suppl.lba6

Abstract

LBA6 Background: Calcium (Ca) and vitamin D (D) have been associated with reduced breast cancer and breast density in observational studies. Randomized trials have not evaluated Ca/D supplementation for breast cancer prevention. Methods: We randomized 36,282 postmenopausal women without prior breast cancer from 40 WHI centers to 1000 mg of elemental calcium as calcium carbonate and 400 IU of vitamin D3 (N = 18,176) daily or matching placebo (N = 18,106); 54% were also randomized one year previously to hormone therapy (HT) or placebo; conjugated equine estrogen (CEE) plus medroxyprogesterone acetate or CEE alone (the latter for those with prior hysterectomy). Ca/D effects on hip fracture and colorectal cancer have been reported (NEJM 2006). We report here pathologically confirmed invasive breast cancer as a secondary outcome of the Ca/D trial. Baseline serum 25(OH) D levels (in 1787 women) and serial joint symptoms (pain/stiffness and hand/feet swelling 0–3 scale, in a 6% sample) were also assessed. Results: Breast cancer incidence did not differ between Ca/D and placebo randomization groups (528 and 546 cases in Ca/D and placebo; hazard ratio 0.96; 95 percent confidence interval (CI), 0.85, 1.09). While SEER stage and abnormal mammogram frequency were similar between groups, breast cancers were smaller in the Ca/D group (1.54 cm (1.23), mean (SD) versus 1.71 (1.29), P = 0.05). Total vitamin D baseline intake was associated with lower breast cancer risk in the placebo group. Baseline vitamin D (nmol per liter) deficiency was common (≥30, sufficient (n = 266), 16 ≤ 30, insufficient (277), < 16, deficient (743)) but was not related to joint pain (seen in 72.2%, 74.0%, 74.6%, of sufficiency and deficiency groups, respectively). Joint symptoms were lower in women randomized to CEE alone (P < 0.01) but did not significantly differ by Ca/D group assignment and no significant interactions were seen between HT and Ca/D. Conclusion: Among healthy postmenopausal women, Ca/D supplementation did not reduce breast cancer risk but the cancers in those randomized to Ca/D were somewhat smaller. Exogenous estrogen use but not Ca/D supplementation influences arthralgias. [Table: see text]

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Title: The Women’s Health Initiative randomized trial of calcium plus vitamin D: Effects on breast cancer and arthralgias
Creators: R. T Chlebowski - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
K. C Johnson - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
C Kooperberg - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
A Hubbell - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
D Lane - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
M O’Sullivan - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
S Cummings - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
T Rohan - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
S Yasmeen - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
J Khandekar - Los Angeles Biomedical Research Insitute, Torrance, CA; University of Tennessee, Germantown, TN; Fred Hutchinson Cancer Research Center, Seattle, WA; University of California Irvine, Orange, CA; The State Univeristy of New York, Stony Brook, NY; University of Miami, Miami, FL; University of California at San Francisco, San Francisco, CA; Albert Einstein College of Medicine, Bronx, NY; University of California at Davis, Sacramento, CA; Women’s Health Initiative, Evanston, IL
Publication Details: Journal of clinical oncology, Vol.24(18_suppl), pp.LBA6-LBA6
Language: English
Resource Type: Journal article
Record Identifier: 991031597896702976