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Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65–71 years: a 3-year randomized population-based trial (OSTPRE-FPS)

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Abstract

Summary

The Osteoporosis Risk Factor and Prevention-Fracture Prevention Study (OSTPRE-FPS) was a randomized population-based open trial (n = 593). The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo. Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women.

Introduction

Vitamin D deficiency is common in the elderly, and vitamin D levels are associated with low bone mineral density (BMD). The working hypothesis was that vitamin D and calcium supplementation could prevent bone loss in ambulatory postmenopausal women.

Methods

The OSTPRE-FPS was a randomized population-based open trial with a 3-year follow-up in 3,432 women (aged 66 to 71 years). A randomly selected subsample of 593 subjects underwent BMD measurements. The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo.

Results

In the intention-to-treat analysis, total body BMD (n = 362) increased significantly more in the intervention group than in the control group (0.84% vs. 0.19%, p = 0.011). The BMD change differences at the lumbar spine (p = 0.372), femoral neck (p = 0.188), trochanter (p = 0.085), and total proximal femur (p = 0.070) were statistically nonsignificant. Analyses in compliant women (≥80% of use) resulted in stronger and statistically significant effects at the total body and femoral regions.

Conclusion

Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women with adequate nutritional calcium intake.

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Acknowledgements

We thank Ms. Seija Oinonen for technical support and Dr. Ewen MacDonald for linguistic check and local pharmacies for drug delivery. Supported by Finnish Cultural Foundation (Hulda Tossavainen Foundation; M.K.), Sigrid Juselius Foundation (H.K.), Academy of Finland (M.T. and J.S.), Kuopio University Hospital EVO grant, and Leiras-Nycomed Ltd. for the calcium and vitamin D supplementation. The study result has been presented at the 54th Nordic Orthopedic Federation Congress, June 11–13, 2008, Amsterdam, Netherlands.

Conflicts of interest

None.

Authors’ contributions

Author M.K. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Authors M.T., R.H., E.A., and H.K. designed the study and directed its implication. Authors M.K., K.S., L.S., R.H., and H.K. analyzed and interpreted the data. Author K.S. helped to prepare the materials and methods section. Author M.K. drafted the manuscript. Authors M.T., K.S., T.R., J.S., R.H., J.A., E.A., and H.K. made critical revision of the manuscript for the important intellectual content.

Author information

Authors and Affiliations

  1. Bone and Cartilage Research Unit, Mediteknia Building, University of Kuopio, P.O. Box 1627, 70211, Kuopio, Finland

    M. Kärkkäinen, M. Tuppurainen, K. Salovaara, T. Rikkonen, J. Sirola, R. Honkanen & H. Kröger

  2. Department of Obstetrics and Gynecology, Kuopio University Hospital, Kuopio, Finland

    M. Tuppurainen

  3. Department of Orthopedics, Traumatology, and Hand Surgery, Kuopio University Hospital, Kuopio, Finland

    K. Salovaara, J. Sirola & H. Kröger

  4. Department of Internal Medicine, Kuopio University Hospital, Kuopio University Hospital, Kuopio, Finland

    L. Sandini

  5. Research Institute of Public Health, University of Kuopio, Kuopio, Finland

    R. Honkanen

  6. Department of Physics, University of Kuopio, Kuopio, Finland

    J. Jurvelin

  7. Institute of Clinical Medicine, Surgery, University of Kuopio, Kuopio, Finland

    E. Alhava

Authors
  1. M. Kärkkäinen
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  2. M. Tuppurainen
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  3. K. Salovaara
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  7. R. Honkanen
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  8. J. Jurvelin
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  9. E. Alhava
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  10. H. Kröger
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Corresponding author

Correspondence to M. Kärkkäinen.

Additional information

The trial has been registered in Clinicaltrials.gov at identifier NCT00592917 (registration date: January 2nd 2008).

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Kärkkäinen, M., Tuppurainen, M., Salovaara, K. et al. Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65–71 years: a 3-year randomized population-based trial (OSTPRE-FPS). Osteoporos Int 21, 2047–2055 (2010). https://doi.org/10.1007/s00198-009-1167-8

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