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Vitamin D3 and calcium supplements reduce hip and nonvertebral fracture rates in elderly women1

In a randomized placebo-controlled study published in the New England Journal of Medicine, 3,270 healthy ambulatory women with a mean [±SD] age of 84±6 years were randomized to 800IU of vitamin D3 and 1.2 g of elemental calcium or placebo for 18 months.

Women who had recently received drugs known to alter bone metabolism were excluded. Women with a history of a fracture and women who had taken or were taking estrogen or a thiazide diuretic were included.

Of the 1,765 women who completed the study, in the treatment vs. the placebo group

Hip fractures

43% lower

(21 vs. 37, P = 0.043)

Nonvertebral fractures

32% lower

(66 vs. 97, P = 0.015)

Common side effects* were nausea, diarrhea, or epigastric pain experienced by 40 in the treatment group and 28 in the placebo group —that led to the discontinuation of treatment (P>0.05). One woman in the treatment group developed mild hypercalcemia (11.2 mg per deciliter [2.8 mmol per liter]) that proved to be due to primary hyperparathyroidism.

In conclusion, 18 months of daily supplementation with 1.2 g of elemental calcium and 800 IU of vitamin D3 decreased the incidence of hip fractures and other nonvertebral fractures among elderly women.

*For more information on the adverse event profile of CALCI-D please see the Prescribing Information.

NICE recommend that calcium and/or vitamin D supplementation should be provided to women who receive treatment for osteoporosis, unless clinicians are confident that women have an adequate calcium intake and are vitamin D replete.2

CALCI-D is licensed for correction of calcium and vitamin D deficiency in the elderly. CALCI-D may be used as an adjunct to specific therapy for osteoporosis, in patients with either established vitamin D and calcium combined deficiencies or in those patients at high risk of needing such therapeutic supplements. This study did not use CALCI-D.

References
1.Chapuy MC et al. N Engl J Med 1992; 327:1637-1642. DOI: 10.1056/NEJM199212033272305
2.National Institute for Health and Care Excellence. Technology appraisal guidance 161. Updated 2018. Available at: http://www.nice.org.uk/guidance/ta161 [Last accessed March 2021].

UK-CAD-191
April 2021