Effect of vitamin D3 and calcium on fracture risk in 65- to 71-year-old women: A population-based 3-year randomized, controlled trial—the OSTPRE-FPS

Authors

  • Kari Salovaara,

    Corresponding author
    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Department of Orthopedics, Traumatology and Handsurgery, Kuopio University Hospital, Kuopio, Finland
    • Bone and Cartilage Research Unit, Clinical Research Centre, Mediteknia Building, University of Kuopio, P.O. Box 1627, 70211 Kuopio, Finland.
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  • Marjo Tuppurainen,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Department of Obstetrics and Gynecology, Kuopio University Hospital, Kuopio, Finland
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  • Matti Kärkkäinen,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
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  • Toni Rikkonen,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
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  • Lorenzo Sandini,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Department of Internal Medicine, Kuopio University Hospital, Kuopio, Finland
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  • Joonas Sirola,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Department of Orthopedics, Traumatology and Handsurgery, Kuopio University Hospital, Kuopio, Finland
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  • Risto Honkanen,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
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  • Esko Alhava,

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Institute of Clinical Medicine, Surgery, University of Kuopio, Kuopio, Finland
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  • Heikki Kröger

    1. Bone and Cartilage Research Unit, University of Kuopio, Kuopio, Finland
    2. Department of Orthopedics, Traumatology and Handsurgery, Kuopio University Hospital, Kuopio, Finland
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  • Results of this study were presented in preliminary form at the 29th Annual Meeting of American Society of Bone and Mineral Research and at the 35th European Symposium on Calcified Tissues.

Abstract

Antifracture efficacy of high-dose vitamin D (800 IU) and calcium (1000 mg) remains controversial. To determine whether daily 800 IU of vitamin D and 1000 mg of calcium supplementation prevents fractures, we randomized 3432 women of the population-based Osteoporosis Risk Factor and Prevention (OSTPRE) Study cohort (ages 65 to 71 years) living in the region of northern Savonia, Finland (latitude 62° to 64°N) for 3 years to receive 800 IU of cholecalciferol and 1000 mg of calcium as calcium carbonate or to a control group that did not receive placebo. The main outcome measure was incident fractures. Fracture data were collected in telephone interviews and validated. Data on 3195 women, 1586 in the intervention group and 1609 in the control group, were available for analysis. In adjusted Cox proportional hazards models, the risk of any fracture decreased in the vitamin D and calcium group by 17% [adjusted hazard ratio (aHR) = 0.83; 95% confidence interval (CI) 0.61–1.12], and the risk of any nonvertebral fracture decreased by 13% (aHR = 0.87; 95% CI 0.63–1.19). The risk of distal forearm fractures decreased by 30% (aHR = 0.70; 95% CI 0.41–1.20), and the risk of any upper extremity fractures decreased by 25% (aHR = 0.75; 95% CI 0.49–1.16), whereas the risk of lower extremity fractures remained essentially equal (aHR = 1.02; 95% CI 0.58–1.80). None of these effects reached statistical significance. In conclusion, this study did not produce statistically significant evidence that vitamin D and calcium supplementation prevents fractures in a 65- to 71-year-old general population of postmenopausal women. © 2010 American Society for Bone and Mineral Research. © 2010 American Society for Bone and Mineral Research

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