Raloxifene to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer: a randomized controlled trial.
GnRH agonists decrease bone mineral density and increase fracture risk in men with prostate cancer. Raloxifene increases bone mineral density in postmenopausal women, but its efficacy in hypogonadal men is not known. In a 12-month open-label study, men with nonmetastatic prostate cancer (n = 48) who were receiving a GnRH agonist were assigned randomly to raloxifene (60 mg/d) or no raloxifene. Bone mineral densities of the posteroanterior lumbar spine and proximal femur were measured by dual energy x-ray absorptiometry. Mean (+/-se) bone mineral density of the posteroanterior lumbar spine increased by 1.0 +/- 0.9% in men treated with raloxifene and decreased by 1.0 +/- 0.6% in men who did not receive raloxifene (P = 0.07). Bone mineral density of the total hip increased by 1.1 +/- 0.4% in men treated with raloxifene and decreased by 2.6 +/- 0.7% in men who did not receive raloxifene (P < 0.001). Similar between-group differences were observed in the femoral neck (P = 0.06) and trochanter (P < 0.001). In men receiving a GnRH agonist, raloxifene significantly increases bone mineral density of the hip and tends to increase bone mineral density of the spine.
Smith
Matthew R
MR
Division of Hematology and Oncology, Massachusetts General Hospital, Boston, Massachusetts 02114, USA. smith.matthew@mgh.harvard.edu
Fallon
Mary Anne
MA
Lee
Hang
H
Finkelstein
Joel S
JS
D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D016723:Bone Remodeling; D004311:Double-Blind Method; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D011655:Pulmonary Embolism / Q000139:chemically induced; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood
D015415:Biomarkers; D020845:Selective Estrogen Receptor Modulators; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; D020849:Raloxifene Hydrochloride