Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation

Osteoporos Int. 2007 Jun;18(6):811-8. doi: 10.1007/s00198-006-0309-5. Epub 2007 Feb 15.

Abstract

Introduction: Osteoporotic fractures in older people are a major and increasing public health problem. We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation.

Methods: In a pragmatic double blind randomised controlled trial of 3 years duration, we examined 3,440 people (2,624 women and 816 men) living in residential or care home. We used four-monthly oral supplementation using 100,000 IU vitamin D(2) (ergocalciferol). As a main outcome measure, we used the incidence of first fracture using an intention to treat analysis. This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales, UK.

Results: The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up (7 fractures per 100 people per year of follow-up), with 218 first fractures in the control group over 2,860 person years of follow-up. The hazard ratio of 0.95 (95% confidence interval 0.79-1.15) for intervention compared to control was not statistically significant.

Conclusion: Supplementation with four-monthly 100,000 IU of oral vitamin D(2) is not sufficient to affect fracture incidence among older people living in institutional care.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Bone Density Conservation Agents / administration & dosage
  • Bone Density Conservation Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Ergocalciferols / administration & dosage
  • Ergocalciferols / therapeutic use*
  • Female
  • Fractures, Bone / etiology
  • Fractures, Bone / prevention & control*
  • Homes for the Aged
  • Humans
  • Male
  • Nursing Homes
  • Osteoporosis / complications
  • Osteoporosis / drug therapy
  • Survival Analysis
  • Treatment Outcome

Substances

  • Bone Density Conservation Agents
  • Ergocalciferols