Raloxifene administration in women treated with gonadotropin-releasing hormone agonist for uterine leiomyomas: effects on bone metabolism.
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.
D000328:Adult; D015992:Body Mass Index; D015519:Bone Density; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism*; D002118:Calcium / Q000097:blood; D003692:Delayed-Action Preparations; D005260:Female; D005269:Femur; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D016729:Leuprolide / Q000009:adverse effects* / Q000627:therapeutic use; D008159:Lumbar Vertebrae; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control; D010758:Phosphorus / Q000097:blood; D010919:Placebos; D017697:Premenopause; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D014594:Uterine Neoplasms / Q000188:drug therapy*
D003692:Delayed-Action Preparations; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D010758:Phosphorus; D020849:Raloxifene Hydrochloride; D016729:Leuprolide; D002118:Calcium