Ipriflavone, a synthetic isoflavone derived flavonoid, is known to have inhibitory effect on bone resorption by inhibiting osteoclastic activity, because ipriflavone does not possess any estrogenic activity, it has no risk of breast or
endometrial
cancer. The purposes of this study were to evaluate the effect of ipriflavone on the bone mineral density, bone mineral density, and low back pain in the postmenopausal women, and to compare the effect of ipriflavone alone with those of premarin
or
premarin plus ipriflavone. Sixty postmenopausal women were randomly submitted to the 4 groups of treatment with 600mg of ipriflavone divided in 3 doses daily by oral administration(Group 1), placebo(Group II), 0.625mg of premarin once a day(Group
III),
and 0.625mg of premarin once a day plus 600mg of ipriflavone divided in 3 doses daily by oral administration(Group IV). All women were given with 1g/day of calcium supplementation. In all subjects, bone mineral density(BMD) of lumbar spine and
femur
neck, urinary calcium/creatinine ratio. and the symptom scores for low back pain were measured before treatment and after 3 and 6 months of treatment.
BMD of femur neck in Group I, Group III and Group IV increased significantly(P<0.05) compared to basal level at 3 months and/or 6 months of treatment. As for BMD of lumbar spine it increased significantly during the treatment in Group III and
Group
IV
but not in Group I and Group II. BMD of lumbar spine and femur neck in Group IV was significantly higher than that in Group III. Urinary calcium/creatinine ratio in Group I, Group III, and Group IV decreased significantly at 3 months and 6 months
of
treatment compared with Group II. There was a decrease in symptom score for low back pain in Group I, Group III and Group IV whereas Group II did not show any significant change.
These data suggest that ipriflavone has the effect of inhibiting bone resorption and relieving low back pain in postmenopausal women and that it enhances the protective effect of estrogens on bone mineral density.
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