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Raloxifene Modulates Interleukin-6 and Tumor Necrosis Factor- Synthesis in Vivo: Results from a Pilot Clinical Study

Unità Operativa Geriatria Oncologica, INRCA (W.G.), Rome, Italy; Departments of Biochemical Sciences (A.R., M.B., S.A., R.S.), Experimental Medicine (P.G., F.P., A.M.A.), Geriatrics (M.P., V.M.), Medical Physiopathology (S.M., G.S.), University of "La Sapienza," 00161 Rome, Italy; Hospital San Carlo-IDI Sanità (S.V.), 00100 Rome, Italy; and University of Siena, Siena, Italy, and Eli Lilly & Co. (D.A.), 50019 Florence, Italy

Address all correspondence and requests for reprints to: Dr. Silvia Migliaccio, Dipartimento di Fisiopatologia Medica, Università "La Sapienza," Policlinico Umberto I, Viale del Policlinico 155, 00161 Rome, Italy. E-mail: silvia.migliaccio{at}uniroma1.it.

Raloxifene (RAL), a selective estrogen receptor modulator, is indicated for the prevention and treatment of postmenopausal osteoporosis. RAL, by decreasing bone turnover, prevents bone loss and microarchitecture damage, reducing the incidence of osteoporotic fractures. Our previous in vitro data demonstrated that RAL modulates osteoclast activity by, at least in part, an IL-6- and TNF--dependent mechanism. In this study we evaluated the effects of RAL treatment (60 mg/d) on circulating levels of these cytokines in 14 postmenopausal women with osteoporosis. Lumbar bone density (determined by dual energy x-ray absorptiometry) and IL-6 and TNF- levels were measured before and after 6 and 24 months of therapy. After 24 months, RAL increased bone density. IL-6 and TNF- expression, elevated before treatment, significantly decreased (50% and 30%, respectively) after 6 months. This effect was sustained up to the end of the treatment (75% and 35%, respectively). Thus, our data show that RAL can modulate circulating levels of cytokines involved in osteoclastogenesis and bone resorption, suggesting that modulation of soluble factors could play a pivotal role in the mechanisms of the osteoprotective effect of RAL.

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