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HRT and Vit D in prevention of non-vertebral fractures in postmenopausal women; a 5 year randomized trial

　　Marja H. Komulainen a,*, Heikki Kro¨ ger b, Marjo T. Tuppurainen a,Anna-Mari Heikkinen a, Esko Alhava b, Risto Honkanen c,d, Seppo Saarikoski a

　　a Department of Obstetrics and Gynecology, Kuopio University Hospital, Kuopio, Finland
　　b Department of Surgery, Kuopio University Hospital, Kuopio, Finland
　　c Institute of Community Medicine, University of Tromso¨ , Tromso¨ , Norway
　　d Research Institute of Public Health, University of Kuopio, Kuopio, Finland

　　Received 9 March 1998; received in revised form 17 July 1998; accepted 20 July 1998

　　Abstract

　　Objectives: We investigated the incidence of new non-vertebral fractures during HRT or low-dose vitamin (Vit) D3 supplementation in a 5-year prospective trial. Methods: A total of 464 early postmenopausal women, (a subgroup of the Kuopio Osteoporosis Study, n = 13100) were randomized to four groups: (1) HRT, a sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate; (2) Vit D (300 IU/day and 100 IU/day during the fifth year); (3) HRT + Vit D; and (4) placebo. Lumbar (L2-4) and femoral neck bone mineral densities (BMD) were determined by dual X-ray absorptiometry (DXA) at baseline, after 2.5 and 5 years of treatment. All new symptomatic non-vertebral, radiographically defined fractures were recorded. Results: Altogether, 368 women (79%) completed the 5 year treatment. In all, 32 women had 39 non-vertebral fractures during a mean of 4.3 year follow-up (HRT 4, Vit D 10, HRT + Vit D 8 and placebo 17). The reduction in the incidence of new non-verterbral fractures was significant in women with HRT alone (P = 0.032) when adjusted by baseline BMD and previous fractures; observed also with the intention-to-treat principle (P = 0.048). When the HRT groups were pooled, HRT showed a significantly lower incidence of new non-vertebral fractures (P = 0.042) than women receiving placebo and also after adjusting as above (P = 0.016); both in valid-case and in the intention-to-treat analysis. In the Vit D group, the fracture incidence was non-significantly decreased (P = 0.229) in comparison with the placebo group. The estimated risk of new non-vertebral fractures among women treated with HRT alone was 0.29 (95% CI, 0.10 - 0.90) and with Vit D 0.47 (95% CI, 0.20 - 1.14) and with HRT + Vit D 0.44 (95% CI, 0.17 - 1.15), in comparison with the placebo group (adjusted by femoral BMD and previous fractures). Conclusions: This study is the first prospective trial confirming the beneficial effect of HRT on prevention of peripheral fractures in non-osteoporotic postmenopausal women. The effect of low-dose Vit D remains to be proved.? 1998 Elsevier Science Ireland Ltd. All rights reserved.

　　Keywords: Fracture risk; Hormone replacement therapy; Osteoporosis; Menopause; Vitamin D3