A double blind, placebo-controlled trial of ipriflavone for prevention of postmenopausal spinal bone loss.
One hundred ninety-eight postmenopausal women (aged 50-65 years) with vertebral bone density (VBD) 1 SD below the mean value for normal, age-matched, postmenopausal subjects were enrolled in six Italian centers and 134 completed 2 years of treatment. All subjects were randomly allocated to a 2-year treatment with oral ipriflavone (200 mg t.i.d.) or a matching placebo, according to a double-blind, parallel group design. All patients also received an oral daily calcium supplement of 1 g as calcium carbonate. VBD and markers of bone turnover were measured at baseline, and every 6 months. A complete routine analysis of liver and kidney functions along with hematological parameters were measured before and at the end of treatment period. The valid completers analysis showed a significant increase of VBD in ipriflavone-treated women with average percent changes of +1.4 after 1 year, and +1% at the end of treatment period (P < 0.05). The placebo group presented a significant decrease of VBD after 2 years of treatment (P < 0.05). The difference between treatments was significant (P < 0.01). The intention to treat analysis confirmed the significant decrease of VBD in the placebo group, with no changes in ipriflavone-treated women. Skeletal ALP significantly decreased in ipriflavone-treated women (P < 0.05). Serum BGP and urine HOP/Cr showed a significant decrease only in ipriflavone-treated women, suggesting an inhibitory effect on bone turnover rate. Adverse reactions, mainly gastrointestinal, occurred to a similar extent in the two treatment groups. The evaluation of patients' compliance, assessed by residual tablets count, revealed a drug intake of more than 80% after 2 years in 92.5% and 92.8% of patients treated with ipriflavone or placebo, respectively. This study demonstrates that ipriflavone can prevent bone loss in postmenopausal women with low bone mass.
Agnusdei
D
D
Institute of Internal Medicine and Medical Pathology, University of Siena, Nuovo Policlinico, Viale Bracci I-53100-Siena, Italy.
Crepaldi
G
G
Isaia
G
G
Mazzuoli
G
G
Ortolani
S
S
Passeri
M
M
Bufalino
L
L
Gennari
C
C
D000368:Aged; D016723:Bone Remodeling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010349:Patient Compliance; D013122:Spinal Diseases / Q000517:prevention & control*
D007529:Isoflavones; C018986:ipriflavone