| 摘 要： | 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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