IPRIFLAVONE-TREATMENT OF SENILE OSTEOPOROSIS - RESULTS OF A MULTICENTER, DOUBLE-BLIND CLINICAL-TRIAL OF 2 YEARS

Eighty-four out of 100 enrolled female patients affected by osteoporos is completed a double-blind, randomized trial, using ipriflavone (IF) in a dose of 3 x 200 mg/day (41 patients) or placebo (P) (43 patients) . All patients received 1 g/day oral calcium supplementation. Inclusio n criteria were: age over 65 years; at least one vertebral fracture in the past; bone mineral density measured at the distal tenth of the ra dius lower than the normal average - 2 x S.D. The trial period was bet ween June 1990 and November 1993. Patients of the IP group showed a si gnificant increase in bone mineral density (P < 0.05) compared with th e starting values during the whole study period, Pain decreased rapidl y, intake of analgesics dropped, and often significant decreases in ca lciuria, hydroxyprolinuria, alkaline phospatase, osteocalcin and parat hormone values were observed, Only two new fractures occurred during t he trial in the IP group, Patients of the P group at the end of the st udy displayed decreased bone mineral densities (P < 0.05), increased p ain, greater consumption of analgesics, and often significant increase s in the bone metabolism parameters listed for the IP group. In the P group 11 new fractures were observed during the study period of 2 year s. The efficacy of IP against osteoporosis was already statistically c onfirmed by the measured markers of bone metabolism and density (P < 0 .05) after 6 months of treatment, and even more after 24 months, as co mpared with the P group. The patients displayed good gastrointestinal tolerance toward IF. Therefore, we consider IP to be an efficient comp ound in the treatment of osteoporosis, especially of senile osteoporos is.osteoporosis was already statistically confirmed by the measured ma rkers of bone metabolism and density ( P < 0.05) after 6 months of tre atment, and even more after 24 months, as compared with the P group. T he patients displayed good gastrointestinal tolerance toward IP. There fore, we consider IP to be an efficient compound in the treatment of o steoporosis, especially of senile osteoporosis.