The capability of ipriflavone to prevent the postmenopausal decline of
bone mineral density (BMD) was evaluated in healthy postmenopausal wo
men (ages 50-60 years) 1-5 years after menopause. In this randomized s
tudy, subjects received I g/day of calcium plus either a placebo or ip
riflavone (200 mg x 3/day; n = 62), for 24 months. At baseline and aft
er 6, 12, 18, and 24 months, BMD was evaluated, along with the biochem
ical parameters of bone metabolism, patient compliance, ability to tol
erate treatment and safety. In group 1 (70 women), BMD was evaluated a
t the distal one-tenth of the nondominant radius by dual photon absorp
tiometry, and in group 2 (40 women) at the lumbar spine (L2-L4) by DEX
A. Drop-outs were three in group 1 and five in group 2. At the distal
radius, BMD decreased significantly (p < 0.0001) during placebo and in
creased during ipriflavone administration. At the lumbar spine, iprifl
avone prevented the decrease of BMD observed during placebo (p < 0.025
). Biochemical and endocrine parameters of bone metabolism were not mo
dified by ipriflavone, except for an increase in circulating calcitoni
n (p < 0.01) and a reduction in the urinary excretion of hydroxyprolin
e (p < 0.02). Patient compliance was good, and ipriflavone was safe an
d well tolerated. Ipriflavone may represent a useful aid for the preve
ntion of BMD decline in postmenopausal women.