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Raloxifene Administration in Women Treated with Gonadotropin-Releasing Hormone Agonist for Uterine Leiomyomas: Effects on Bone Metabolism

Chair of Obstetrics and Gynecology (S.P., M.M., T.R., F.Z.), University of Catanzaro, 88100 Catanzaro, Italy; Departments of Molecular and Clinical Endocrinology and Oncology (F.O., G.L., A.C.) and Gynecology, Obstetrics and Human Reproduction (M.P., C.N.), University of Naples "Federico II", 80131 Naples, Italy; and Department of Obstetrics and Gynecology (P.M.), University of Messina, 98166 Messina, Italy

Address all correspondence and requests for reprints to: Dr. Stefano Palomba, Via Nicolardi 188, Napoli 80131, Italy. E-mail: stefanopalomba{at}tin.it.

Abstract

This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration.

One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B). Bone mineral density (BMD) and serum bone metabolism markers were evaluated at admission and after six treatment cycles.

Posttreatment BMD differed significantly from baseline BMD in group B but not in group A. BMD was significantly higher in group A than in group B. In group A, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were unchanged vs. baseline. Differently, posttreatment concentrations of these bone turnover markers were significantly lower in group B compared with baseline and group A values.

In conclusion, raloxifene prevents GnRH-a related bone loss in premenopausal women with uterine leiomyomas.

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