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Randomized trial comparing low-dose hormone replacement therapy and HRT plus 1α-OH-vitamin D3 (alfacalcidol) for treatment of postmenopausal bone loss

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Abstract

We conducted a prospective, randomized, multicenter, open-label 2-year trial with 76 postmenopausal women aged ≥60 years with low (T-score less than −1) lumbar bone mineral density (BMD). The hormone replacement therapy (HRT) group received a low dose of conjugated estrogen (CEE) at a dose of 0.31 mg/day ± medroxyprogesterone acetate (MPA) 2.5 mg/day. Group HRT/D received the same dose of HRT together with alfacalcidol in a daily dose of 1.0 µg/day. Changes in lumbar BMD measured by dual energy X-ray absorptiometry (DXA) were followed every 6 months for 2 years. The lumbar BMD of group HRT increased 3.37% [95% confidence interval (CI) 1.6%–5.2%], 4.00% (95%CI 1.6%–6.4%), and 2.32% (95%CI −0.7% to 5.3%) at 12, 18, and 24 months, respectively, when the baseline value was taken as 0%. Lumbar BMD of group HRT/D showed a significant increase beyond 6 months. The percent increases for this group at 6, 12, 18, and 24 months were 6.18 (95%CI 1.3%–6.6%), 6.18% (95%CI 3.9%–8.5%), 7.17% (95%CI 4.3%–10.0%), and 8.75% (95%CI 6.0%–11.5%), respectively. In addition, there was a significant difference in the changes of the lumbar BMD between the two groups at 24 months, suggesting that the combination of HRT and alfacalcidol is more effective than HRT alone in terms of the BMD effect. This study is the first prospective trial demonstrating an additive effect of alfacalcidol on lumbar BMD in postmenopausal women receiving low-dose HRT. It suggests that the combination therapy can be considered to be a promising mode of treatment for bone loss after menopause.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Hirosaki University School of Medicine, 5-Zaifu-cho, Hirosaki, 036-8562, Japan

    Hideki Mizunuma

  2. Research Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano, Japan

    Masataka Shiraki

  3. Department of Obstetrics and Gynecology, Narakenritsu Mimuro Hospital, Nara, Japan

    Masafumi Shintani

  4. Department of Obstetrics and Gynecology, International University of Health and Welfare, Atami Hospital, Atami, Japan

    Itsuo Gorai

  5. Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo, Japan

    Kazuya Makita

  6. Department of Obstetrics and Gynecology, Tone Central Hospital, Numata, Japan

    Shunichi Itoga

  7. Department of Obstetrics and Gynecology, Dokkyo University School of Medicine, Tochigi, Japan

    Yoshiko Mochizuki

  8. Department of Obstetrics and Gynecology, Maebashi Kyouritu Hospital, Maebashi, Japan

    Hiromichi Mogi

  9. Department of Obstetrics and Gynecology, Kouseiren Yoshida General Hospital, Hiroshima, Japan

    Yasuhisa Iwaoki

  10. Department of Obstetrics and Gynecology, Kagoshima University School of Medicine, Kagoshima, Japan

    Shouichirou Kosha

  11. Department of Obstetrics and Gynecology, Tokushima University School of Medicine, Tokushima, Japan

    Toshiyuki Yasui

  12. Department of Obstetrics and Gynecology, Saitama Medical School, Saitama, Japan

    Osamu Ishihara

  13. Department of Obstetrics and Gynecology, Niigata University School of Medicine, Niigata, Japan

    Takumi Kurabayashi

  14. Department of Obstetrics and Gynecology, Ashikaga Red Cross Hospital, Tochigi, Japan

    Yoshio Kasuga

  15. Department of Basic Allied Medicine, School of Health Sciences, Faculty of Medicine, Gunma University, Maebashi, Japan

    Kunihiko Hayashi

Authors
  1. Hideki Mizunuma
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  2. Masataka Shiraki
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  3. Masafumi Shintani
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  4. Itsuo Gorai
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  5. Kazuya Makita
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  6. Shunichi Itoga
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  7. Yoshiko Mochizuki
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  8. Hiromichi Mogi
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  9. Yasuhisa Iwaoki
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  10. Shouichirou Kosha
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  11. Toshiyuki Yasui
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  12. Osamu Ishihara
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  13. Takumi Kurabayashi
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  14. Yoshio Kasuga
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  15. Kunihiko Hayashi
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Corresponding author

Correspondence to Hideki Mizunuma.

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Mizunuma, H., Shiraki, M., Shintani, M. et al. Randomized trial comparing low-dose hormone replacement therapy and HRT plus 1α-OH-vitamin D3 (alfacalcidol) for treatment of postmenopausal bone loss. J Bone Miner Metab 24, 11–15 (2006). https://doi.org/10.1007/s00774-005-0639-y

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  • DOI: https://doi.org/10.1007/s00774-005-0639-y

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