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Rheumatology Advance Access originally published online on November 12, 2007
Rheumatology 2007 46(12):1852-1857; doi:10.1093/rheumatology/kem240
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© The Author 2007. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Effect of annual intramuscular vitamin D on fracture risk in elderly men and women—a population-based, randomized, double-blind, placebo-controlled trial

H. Smith, F. Anderson1, H. Raphael, P. Maslin, S. Crozier2 and C. Cooper2

Department of Primary Care, Division of Community-based Clinical Sciences, 1Geriatric Medicine Group and 2MRC Epidemiology Resource Centre, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK.

Correspondence to: C. Cooper, Professor of Rheumatology and Director, MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton SO16 6YD, UK. E-mail: cc{at}mrc.soton.ac.uk


  Abstract

Objectives. Low trauma fractures in older people incur enormous physical, social and economic costs. Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group. This strategy requires validation in a population setting.

Methods. Randomized, double-blind, placebo-controlled trial of 300 000 IU intramuscular (i.m.) vitamin D2 (ergocalciferol) injection or matching placebo every autumn over 3 years. 9440 people (4354 men and 5086 women) aged 75 yrs and over were recruited from general practice registers in Wessex, England. Primary outcome measure was all non-vertebral fracture. Secondary outcomes were hip and wrist fractures, and all falls.

Results. 585 subjects had incident non-spine fractures (hip 110, wrist 116, ankle 37). Hazard ratios (HRs) for fracture in the vitamin D group were: 1.09 [95% confidence interval (CI) 0.93–1.28, P = 0.29] for any first fracture, 1.49 (95% CI 1.02–2.18, P = 0.04) for hip and 1.22 (95% CI 0.85–1.76, P = 0.28) for wrist. There was no effect on falls: HR 0.98 (0.93–1.04). No protective effect was observed in any subgroup when the cohort was stratified by sex, age, previous fracture or mobility.

Conclusions. An annual i.m. injection of 300 000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population.

KEY WORDS: Fracture, Epidemiology, Osteoporosis, Vitamin D, Prevention

Submitted 10 April 2007; revised version accepted 8 August 2007.
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