Additive effect of alfacalcidol on bone mineral density of the lumbar spine in Taiwanese postmenopausal women treated with hormone replacement therapy and calcium supplementation: a randomized 2-year study
M. Chen et Sn. Chow, Additive effect of alfacalcidol on bone mineral density of the lumbar spine in Taiwanese postmenopausal women treated with hormone replacement therapy and calcium supplementation: a randomized 2-year study, CLIN ENDOCR, 55(2), 2001, pp. 253-258
OBJECTIVE To evaluate the effect of 1 alpha -hydroxyvitamin D-3 on bone min
eral density of the lumbar spine in postmenopausal women receiving hormone
replacement therapy and calcium supplement.
PATIENTS AND MEASUREMENTS A total of 240 postmenopausal women were enrolled
with randomized assignment of 120 patients to each treatment group (the D
+ E group of 1 alpha -hydroxyvitamin D3 + sequential combined HRT + calcium
supplement; the E group: sequential combined HRT + calcium supplement). No
ne of the patients had received HRT for menopausal syndrome or osteoporosis
before being enrolled in our study. Serum biochemical assays, electrolytes
and calcitonin were performed at baseline and after 6 and 12 months of tre
atment. Bone mineral density (BMD) of L2-L4 was measured by dual energy X-r
ay absorptiometry (DXA) at the initial assessment and after 12 and 24 month
s of treatment.
RESULTS One hundred and five patients (87.5%) in the D + E group and 92 pat
ients (76.7%) in the E group completed the first 1-year study. Ninety-six p
atients (80%) in the D + E group and 80 patients (66.7%) In the E group com
pleted the 2-year trial. Renal function, liver function, electrolytes and c
alcitonin showed no significant changes during the first year of follow-up.
In the D + E group, the BMD of L2-4 increased 3.24 +/- 0.32% from baseline
after 1 year (P < 0.05) and 5.32 <plus/minus> 0.23% after 2 years of treat
ment (P < 0.05). On the other hand, the changes of BMD in the E group were
1.12 <plus/minus> 0.34% after 1 year (P < 0.05) and 2.42 <plus/minus> 0.26%
after 2 years of treatment (P < 0.05). The changes of BMD of L2-L4 of the
D + E group were higher than the changes of the E group after both 1 and 2
years of treatment (P < 0.05).
CONCLUSIONS Our study demonstrated that combination of let-hydroxyvitamin D
3 with HRT is superior to HRT alone for the preservation of bone mineral de
nsity in postmenopausal women under calcium supplementation.