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Calcium plus vitamin D supplementation and the risk of fractures

Rebecca D. Jackson
Andrea Z. LaCroix
Margery Gass
Robert B. Wallace
John Robbins
Cora E. Lewis
Tamsen Bassford
Shirley A. A. Beresford
Henry R. Black
Patricia L. Blanchette
Denise E. Bonds
Robert L. Brunner
Robert G. Brzyski
Bette Caan
Jane A. Cauley
Rowan T. Chlebowski
Steven R. Cummings
Iris A. Granek
Jennifer Hays
Gerardo Heiss
Susan L. Hendrix
Barbara V. Howard
Judith Hsia
F. Allan Hubbell
Karen C. Johnson
Howard Judd
Jane Morley Kotchen
Lewis H. Kuller
Robert D. Langer
Norman L. Lasser
Marian C. Limacher
Shari E. Ludlam
JoAnn E. Manson
Karen L. Margolis
Joan McGowan
Judith K. Ockene, University of Massachusetts Medical School
Mary Jo O'Sullivan
Lawrence Phillips
Ross L. Prentice
Gloria E. Sarto
Marcia L. Stefanick
Linda Van Horn
Jean Wactawski-Wende
Evelyn Whitlock
Garnet L. Anderson
Annlouise R. Assaf
David H. Barad

Abstract

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.

METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.

RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels.

CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

Suggested Citation

Rebecca D. Jackson, Andrea Z. LaCroix, Margery Gass, Robert B. Wallace, John Robbins, Cora E. Lewis, Tamsen Bassford, Shirley A. A. Beresford, Henry R. Black, Patricia L. Blanchette, Denise E. Bonds, Robert L. Brunner, Robert G. Brzyski, Bette Caan, Jane A. Cauley, Rowan T. Chlebowski, Steven R. Cummings, Iris A. Granek, Jennifer Hays, Gerardo Heiss, Susan L. Hendrix, Barbara V. Howard, Judith Hsia, F. Allan Hubbell, Karen C. Johnson, Howard Judd, Jane Morley Kotchen, Lewis H. Kuller, Robert D. Langer, Norman L. Lasser, Marian C. Limacher, Shari E. Ludlam, JoAnn E. Manson, Karen L. Margolis, Joan McGowan, Judith K. Ockene, Mary Jo O'Sullivan, Lawrence Phillips, Ross L. Prentice, Gloria E. Sarto, Marcia L. Stefanick, Linda Van Horn, Jean Wactawski-Wende, Evelyn Whitlock, Garnet L. Anderson, Annlouise R. Assaf, and David H. Barad. "Calcium plus vitamin D supplementation and the risk of fractures" The New England journal of medicine 354.7 (2006).
Available at: http://works.bepress.com/ockenej/79