Skip to main content
Log in

Vitamin D and HRT: No benefit additional to that of HRT alone in prevention of bone loss in early postmenopausal women. A 2.5-year randomized placebo-controlled study

  • Original Article
  • Published:
Osteoporosis International Aims and scope Submit manuscript

Abstract

The study was designed to examine the effect of hormone replacement therapy (HRT) and low-dose vitamin D (Vit D) supplementation on the prevention of bone loss in non-osteoporotic early postmenopausal women and to determine whether Vit D supplementation can give additional benefit to an already optimized estrogen regimen. The effects of HRT and Vit D on bone mineral density (BMD) were studied in postmenopausal women in a 2.5-year randomized placebo-controlled study. The study population was a subgroup of the Kuopio Osteoporosis Risk Factor and Prevention Study (OSTPRE) (n=13100). A total of 464 early postmenopausal women were randomized to four groups: (1) HRT (a sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate (E2Val/CPA); (2) vitamin D3 (cholecalciferol, 300 IU/day); (3) HRT+Vit D; and (4) placebo (calcium lactate; 93 mg Ca2+/day). Lumbar (L1–4) and femoral neck BMD were determined by dual-energy X-ray absorptiometry before and after 2.5 years of treatment. After 2.5 years, lumbar BMD had increased by 1.8% in the HRT group (p<0.001) and by 1.4% in the HRT+Vit D group (p=0.002), whereas lumbar BMD had decreased by 3.5% (p<0.001) in the Vit D group and by 3.7% (p<0.001) in the placebo group. The loss of femoral neck BMD was lower in the HRT (−0.3%) and the HRT+Vit D (−0.9%) groups compared with the Vit D (−2.4%) and the placebo groups (−3.7%). This study confirms the beneficial effect of HRT on BMD. It also shows that low-dose vitamin D supplementation has only a minor effect in the prevention of osteoporosis in non-osteoporotic early postmenopausal women and does not give any benefit additional to that of HRT alone.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Hirvonen E, Elliesen J, Schmidt-Gollwitzer K. Comparison of two hormone replacement regimens: influence on lipoproteins and bone mineral content. Maturitas 1990;12:127–36.

    Google Scholar 

  2. Lips P, Wiersinga A, van Ginkel FC, et al. The effect of vitamin D supplementation on vitamin D status and parathyroid function in elderly subjects. J Clin Endocrinol Metab 1988;67:644–50.

    Google Scholar 

  3. Dawson-Hughes B, Dallal GE, Krall EA, Harris S, Sokoll LJ, Falconer G. Effect of vitamin D supplementation on wintertime and overall bone loss in healthy postmenopausal women. Ann Intern Med 1991;115:505–12.

    Google Scholar 

  4. Chapuy MC, Arlot ME, Duboeuf F et al. Vitamin D3 and calcium to prevent hip fractures in elderly women. N Engl J Med 1992;327:1637–42.

    Google Scholar 

  5. Kröger H, Heikkinen J, Laitinen K, Kotaniemi A. Dual-energy X-ray absorptiometry in normal women: a cross-sectional study of 717 Finnish volunteers. Osteoporosis Int 1992;2:135–40.

    Google Scholar 

  6. Christensen MS, Hagen C, Christiansen D, Transbol IB. Dose-response evaluation of cyclic estrogen/gestagen in postmenopausal women: placebo-controlled trial of its gynecologic and metabolic actions. Am J Obstet Gynecol 1982;144:873–9.

    Google Scholar 

  7. Tuppurainen M, Heikkinen AM, Penttilä I, Saarikoski S. Does vitamin D3 have negative effects on serum levels of lipids? A follow-up study with a sequential combination of estradiol valerate and cyproterone acetate and/or vitamin D3. Maturitas 1995;22:55–61.

    Google Scholar 

  8. Marslew U, Overgaard K, Riis BJ, Christiansen C. Two new combinations of estrogen and progestogen for prevention of postmenopausal bone loss: long-term effects on bone, calcium and lipid metabolism, climacteric symptoms, and bleeding. Obstet Gynecol 1992;79:202–10.

    Google Scholar 

  9. Kleemola P, Virtanen M, Pietinen P. The 1992 dietary survey of Finnish adults. Publication of the National Public Health Institute, Helsinki B2/1994.

  10. National Research Council. Recommended dietary allowances: subcommittee on the tenth edition of the RDAs. Food and Nutrition Board, Commission on Life Sciences, National Research Council. Washington, DC: National Academy Press, 1989.

    Google Scholar 

  11. Reid IR, Ames RW, Evans MC, Gamble GD, Sharpe SJ. Long-term effects of calcium supplementation on bone loss and fractures in postmenopausal women: a randomized controlled trial. Am J Med 1995;98:331–5.

    Google Scholar 

  12. Dawson-Hughes B, Dallal GE, Krall EA, Sadowski L, Sahyoun N, Tannenbaum S. A controlled trial of the effect of calcium supplementation on bone density in postmenopausal women. N Engl J Med 1990;323:878–83.

    Google Scholar 

  13. Riis BJ, Jensen J, Christiansen C. Cyproterone acetate, an alternative gestagen in postmenopausal estrogen/gestagen therapy? Clin Endocrinol 1987;26:327–34.

    Google Scholar 

  14. Pouilles JM, Tremollieres F, Ribot C. Effect of menopause on femoral and vertebral bone loss. J Bone Miner Res 1995;10:1531–6.

    Google Scholar 

  15. Holland EFN, Leather AT, Studd JWW, Garnett TJ. The effect of a new sequential oestradiol valerate and levonorgestrel preparation on the bone mineral density of postmenopausal women. Br J Obstet Gynaecol 1993;100:966–7.

    Google Scholar 

  16. Dören M, Reuther G, Minne HW, Schneider HPG. Superior compliance and efficacy of continuous combined oral estrogen-progestogen replacement therapy in postmenopausal women. Am J Obstet Gynecol 1995;173:1446–51.

    Google Scholar 

  17. Kröger H, Huopio J, Honkanen R, et al. Prediction of fracture risk using axial bone mineral density in a perimenopausal population: a prospective study. J Bone Miner Res 1995;10:302–6.

    Google Scholar 

  18. Lips P, Gramans WC, Ooms ME, Bezemer PD, Bouter LM. The effect of vitamin D supplementation on the incidence of hip fractures in elderly people [abstract]. J Bone Miner Res 1994;9(Suppl 1):S148.

    Google Scholar 

  19. Ooms ME, Roos JE, Bezemer PD, van der Vijgh WJ, Bouter LM, Lips P. Prevention of bone loss by vitamin D supplementation in elderly women: a randomized double-blind trial. J Clin Endocrinol Metab 1995;80:1052–8.

    Google Scholar 

  20. Dawson-Hughes B, Harris SS, Krall EA, Dallal GE, Falconer G, Green CL. Rates of bone loss in postmenopausal women randomly assigned to one of two dosages of vitamin D. Am J Clin Nutr 1995;61:1140–5.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to M. Komulainen MD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Komulainen, M., Tuppurainen, M.T., Kröger, H. et al. Vitamin D and HRT: No benefit additional to that of HRT alone in prevention of bone loss in early postmenopausal women. A 2.5-year randomized placebo-controlled study. Osteoporosis Int 7, 126–132 (1997). https://doi.org/10.1007/BF01623687

Download citation

  • Received:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF01623687

Keywords

Navigation