title: 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.
abstract: The study was designed to examine the effect of hormone replacement therapy (HRT) and low-dose 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.
authors.affiliation: Department of Obstetrics and Gynecology, Kuopio University Hospital, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Komulainen
authors.forename: M T
authors.initials: MT
authors.lastname: Tuppurainen
authors.forename: H
authors.initials: H
authors.lastname: Kröger
authors.forename: A M
authors.initials: AM
authors.lastname: Heikkinen
authors.forename: E
authors.initials: E
authors.lastname: Puntila
authors.forename: E
authors.initials: E
authors.lastname: Alhava
authors.forename: R
authors.initials: R
authors.lastname: Honkanen
authors.forename: S
authors.initials: S
authors.lastname: Saarikoski
mesh_terms: D000886:Anthropometry; D015519:Bone Density / Q000187:drug effects*; D004359:Drug Therapy, Combination; D015914:Estrogen Replacement Therapy; D005260:Female; D005272:Femur Neck / Q000502:physiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000502:physiology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D017698:Postmenopause / Q000502:physiology; D011446:Prospective Studies; D014807:Vitamin D / Q000627:therapeutic use*
chemical_list: D014807:Vitamin D