A double blind, placebo-controlled trial of ipriflavone for prevention of postmenopausal spinal bone loss

D. Agnusdei, G. Crepaldi, G. Isaia, G. Mazzuoli, S. Ortolani, M. Passeri, L. Bufalino, C. Gennari, A. Camporeale, C. Cepollaro, S. Gonnelli, S. Giannini, L. Sartori, A. Sciolla, S. Minisola, D. Pisani, F. M. Ulivieri, D. Costi, E. Dall'Aglio, M. Pedrazzoni & 2 others G. N. Castiglione, F. Gardini

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Abstract

One hundred ninety-eight postmenopausal women (aged 50-65 years) with vertebral bone density (VBD) 1 SD below the mean value for normal, agematched, 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 ipriflavonetreated 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.

Original languageEnglish
Pages (from-to)142-147
Number of pages6
JournalCalcified Tissue International
Volume61
Issue number2
DOIs
Publication statusPublished - Aug 1997

Fingerprint

Postmenopausal Osteoporosis
Placebos
Bone Density
Bone Remodeling
Therapeutics
Intention to Treat Analysis
Calcium Carbonate
Patient Compliance
ipriflavone
Tablets
Reference Values
Urine
Calcium
Kidney
Bone and Bones
Liver
Serum
Pharmaceutical Preparations

Keywords

  • Bone loss
  • Bone turnover
  • Ipriflavone
  • Vertebral bone mass

ASJC Scopus subject areas

  • Endocrinology

Cite this

A double blind, placebo-controlled trial of ipriflavone for prevention of postmenopausal spinal bone loss. / Agnusdei, D.; Crepaldi, G.; Isaia, G.; Mazzuoli, G.; Ortolani, S.; Passeri, M.; Bufalino, L.; Gennari, C.; Camporeale, A.; Cepollaro, C.; Gonnelli, S.; Giannini, S.; Sartori, L.; Sciolla, A.; Minisola, S.; Pisani, D.; Ulivieri, F. M.; Costi, D.; Dall'Aglio, E.; Pedrazzoni, M.; Castiglione, G. N.; Gardini, F.

In: Calcified Tissue International, Vol. 61, No. 2, 08.1997, p. 142-147.

Research output: Contribution to journalArticle

Agnusdei, D, Crepaldi, G, Isaia, G, Mazzuoli, G, Ortolani, S, Passeri, M, Bufalino, L, Gennari, C, Camporeale, A, Cepollaro, C, Gonnelli, S, Giannini, S, Sartori, L, Sciolla, A, Minisola, S, Pisani, D, Ulivieri, FM, Costi, D, Dall'Aglio, E, Pedrazzoni, M, Castiglione, GN & Gardini, F 1997, 'A double blind, placebo-controlled trial of ipriflavone for prevention of postmenopausal spinal bone loss', Calcified Tissue International, vol. 61, no. 2, pp. 142-147. https://doi.org/10.1007/s002239900312
Agnusdei, D. ; Crepaldi, G. ; Isaia, G. ; Mazzuoli, G. ; Ortolani, S. ; Passeri, M. ; Bufalino, L. ; Gennari, C. ; Camporeale, A. ; Cepollaro, C. ; Gonnelli, S. ; Giannini, S. ; Sartori, L. ; Sciolla, A. ; Minisola, S. ; Pisani, D. ; Ulivieri, F. M. ; Costi, D. ; Dall'Aglio, E. ; Pedrazzoni, M. ; Castiglione, G. N. ; Gardini, F. / A double blind, placebo-controlled trial of ipriflavone for prevention of postmenopausal spinal bone loss. In: Calcified Tissue International. 1997 ; Vol. 61, No. 2. pp. 142-147.
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