Effect of ipriflavone--a synthetic derivative of natural isoflavones--on bone mass loss in the early years after menopause.
OBJECTIVE
We studied whether oral administration of ipriflavone, a synthetic derivative of naturally occurring isoflavones, could prevent bone loss occurring shortly after menopause.


METHODS
Fifty-six women with low vertebral bone density and with postmenopausal age less than five years were randomly allocated to receive either ipriflavone, 200 mg three times daily, or placebo. All subjects also received 1,000 mg elemental calcium daily.


RESULTS
Vertebral bone density declined after two years in women taking only calcium (4.9 +/- 1.1%, SEM, p = 0.001), but it did not change in those receiving ipriflavone (-0.4 +/- 1.1%, n.s.). A significant (p = 0.010) between-treatment difference was evidenced at both year 1 and year 2. At the end of the study, urine hydroxyproline/creatinine excretion was higher in the control group than in the ipriflavone group, as compared to no difference at baseline. Five patients taking ipriflavone and five taking placebo experienced gastrointestinal discomfort or other adverse reactions, but only one and four subjects, respectively, had to discontinue the study.


CONCLUSIONS
Ipriflavone prevents the rapid bone loss following early menopause. This effect is associated with a reduction of bone turnover rate.
Gennari
C
C
Internal Medicine and Medical Pathology Institute, University of Siena, Italy.
Agnusdei
D
D
Crepaldi
G
G
Isaia
G
G
Mazzuoli
G
G
Ortolani
S
S
Bufalino
L
L
Passeri
M
M
D000284:Administration, Oral; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000097:blood / Q000652:urine; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000008:administration & dosage / Q000627:therapeutic use / Q000652:urine; D015331:Cohort Studies; D003404:Creatinine / Q000652:urine; D005260:Female; D006801:Humans; D006909:Hydroxyproline / Q000652:urine; D007529:Isoflavones / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D013131:Spine / Q000187:drug effects / Q000502:physiology
D015415:Biomarkers; D007529:Isoflavones; D015675:Osteocalcin; C018986:ipriflavone; D003404:Creatinine; D000469:Alkaline Phosphatase; D006909:Hydroxyproline; D002118:Calcium