Calcium plus vitamin D supplementation and the risk of fractures.

The New England journal of medicine
Q1
Feb 2006
Citations:1812
Influential Citations:57
Interventional (Human) Studies
91
COI
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Methods
Randomized, double-blind, placebo-controlled trial within the Women's Health Initiative. Participants were postmenopausal women aged 50–79 years (N=36,282) enrolled in WHI trials; randomly assigned to calcium with vitamin D or placebo; follow-up about 7 years; healthy participants.
Intervention
Calcium carbonate providing 1000 mg elemental calcium daily plus vitamin D 400 IU daily; taken as two 500 mg tablets per day with meals; duration about 7 years (mean follow-up).
Results
Calcium with vitamin D supplementation increased hip bone mineral density by about 1.06% over the study period (P<0.01) but did not significantly reduce hip fracture (hazard ratio 0.88, 95% CI 0.72–1.08). There were no significant reductions in clinical spine fracture or total fractures. Kidney stones were more frequent with calcium plus vitamin D (hazard ratio 1.17, 95% CI 1.02–1.34). Among adherent participants (≥80% adherence), hip fracture risk decreased by 29% (hazard ratio 0.71, 95% CI 0.52–0.97). Authors conclude a small improvement in hip bone density but no meaningful fracture reduction and an increased risk of kidney stones; results do not support universal calcium with vitamin D supplementation for fracture prevention in healthy postmenopausal women, though adherence may influence outcomes.
Limitations
Lower-than-expected hip-fracture rate reduced study power to detect modest fracture reductions (approximately 48% power). Cannot separate effects of calcium and vitamin D; population not calcium/vitamin D deficient at baseline; high baseline calcium and vitamin D intakes; adherence declined over time; concurrent use of hormone therapy and other osteoporosis medications may confound results.

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 en...