Original Article

Osteoporosis International

, Volume 7, Issue 2, pp 126-132

First online:

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

  • M. KomulainenAffiliated withDepartment of Obstetrics and Gynecology, Kuopio University HospitalThe A.I. Virtanen Institute, University of Kuopio Email author 
  • , M. T. TuppurainenAffiliated withDepartment of Obstetrics and Gynecology, Kuopio University HospitalThe A.I. Virtanen Institute, University of Kuopio
  • , H. KrögerAffiliated withThe A.I. Virtanen Institute, University of KuopioDepartment of Surgery, Kuopio University Hospital
  • , A. M. HeikkinenAffiliated withDepartment of Obstetrics and Gynecology, Kuopio University HospitalThe A.I. Virtanen Institute, University of Kuopio
  • , E. PuntilaAffiliated withThe A.I. Virtanen Institute, University of Kuopio
  • , E. AlhavaAffiliated withThe A.I. Virtanen Institute, University of KuopioDepartment of Surgery, Kuopio University Hospital
  • , R. HonkanenAffiliated withThe A.I. Virtanen Institute, University of KuopioInstitute of Community Medicine, University of Tromsö
  • , S. SaarikoskiAffiliated withDepartment of Obstetrics and Gynecology, Kuopio University HospitalThe A.I. Virtanen Institute, University of Kuopio

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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.

Keywords

Bone mineral density Cyproterone acetate Hormone replacement therapy Osteoporosis Postmenopause Vitamin D