The Journal of Urology
Volume 179, Issue 1 , Pages 152-155 , January 2008

Toremifene Increases Bone Mineral Density in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Interim Analysis of a Multicenter Phase 3 Clinical Study

  • M.R. Smith

      Affiliations

    • Massachusetts General Hospital, Boston, Massachusetts
    • Financial interest and/or other relationship with GTx, Amgen and Novartis.
    • Corresponding Author InformationCorrespondence: Massachusetts General Hospital Cancer Center, Yawkey 7038, 55 Fruit St., Boston, Massachusetts 02114 (telephone: 617-724-5257; FAX: 617-726-4899).
    • ,
  • S.B. Malkowicz

      Affiliations

    • University of Pennsylvania, Philadelphia, Pennsylvania
    • Financial interest and/or other relationship with GTx and Sanofi Aventis.
    • ,
  • F. Chu

      Affiliations

    • San Bernadino Urology Associates, San Bernadino, California
    • Financial interest and/or other relationship with GTx, GlaxoSmithKline, Pfizer, Ortho Urology and Sanofi.
    • ,
  • J. Forrest

      Affiliations

    • Urology Specialists of Oklahoma, Tulsa, Oklahoma
    • Financial interest and/or other relationship with Ortho McNeil, GTx, Amgen, Allergan and Unigen.
    • ,
  • D. Price

      Affiliations

    • Regional Urology, Shreveport, Louisiana
    • Financial interest and/or other relationship with GTx and Intuitive Surgical.
    • ,
  • P. Sieber

      Affiliations

    • Urology Associates of Lancaster, Lancaster, Pennsylvania
    • Financial interest and/or other relationship with GTx, GlaxoSmithKline, Bayer, Merck, AstraZeneca, Cell Genesys, Wilox, Astellas, Spectrum, Allergan, Schwerz, Amgen, Sanofi Synthelabo and Aureon Laboratories.
    • ,
  • K.G. Barnette

      Affiliations

    • GTx, Inc., Memphis, Tennessee
    • Financial interest and/or other relationship with GTx.
    • ,
  • D. Rodriguez

      Affiliations

    • GTx, Inc., Memphis, Tennessee
    • Financial interest and/or other relationship with GTx.
    • ,
  • M.S. Steiner

      Affiliations

    • GTx, Inc., Memphis, Tennessee
    • Financial interest and/or other relationship with GTx.

Received 11 April 2007

References 

  1. Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA. 2005;294:238
  2. Barry MJ, Delorenzo MA, Walker-Corkery ES, Lucas FL, Wennberg DC. The rising prevalence of androgen deprivation among older American men since the advent of prostate-specific antigen testing: a population-based cohort study. BJU Int. 2006;98:973
  3. Lee H, McGovern K, Finkelstein JS, Smith MR. Changes in bone mineral density and body composition during initial and long-term gonadotropin-releasing hormone agonist treatment for prostate carcinoma. Cancer. 2005;104:1633
  4. Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005;352:154
  5. Smith MR, Lee WC, Brandman J, Wang Q, Botteman M, Pashos CL. Gonadotropin-releasing hormone agonists and fracture risk: a claims-based cohort study of men with nonmetastatic prostate cancer. J Clin Oncol. 2005;23:7897
  6. Oefelein MG, Ricchiuti V, Conrad W, Resnick MI. Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol. 2002;168:1005
  7. Slemenda CW, Longcope C, Zhou L, Hui SL, Peacock M, Johnston CC. Sex steroids and bone mass in older men (Positive associations with serum estrogens and negative associations with androgens). J Clin Invest. 1997;100:1755
  8. Khosla S, Melton LJ, Atkinson EJ, O’Fallon WM, Klee GG, Riggs BL. Relationship of serum sex steroid levels and bone turnover markers with bone mineral density in men and women: a key role for bioavailable estrogen. J Clin Endocrinol Metab. 1998;83:2266
  9. Greendale GA, Edelstein S, Barrett-Connor E. Endogenous sex steroids and bone mineral density in older women and men: the Rancho Bernardo Study. J Bone Miner Res. 1997;12:1833
  10. Gardsell P, Johnell O, Nilsson BE. The predictive value of forearm bone mineral content measurements in men. Bone. 1990;11:229
  11. Van der Klift M, De Laet CE, McCloskey EV, Hofman A, Pols HA. The incidence of vertebral fractures in men and women: the Rotterdam Study. J Bone Miner Res. 2002;17:1051
  12. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial (Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators). JAMA. 1999;282:637
  13. Steiner MS, Patterson A, Israeli R, Barnette KG, Boger R, Price D. Toremifene citrate versus placebo for treatment of bone loss and other complications of androgen deprivation therapy in patients with prostate cancer. J Clin Oncol, suppl. 2004;22:abstract 4597.
  14. Smith MR, Fallon MA, Lee H, Finkelstein JS. Raloxifene to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer: a randomized controlled trial. J Clin Endocrinol Metab. 2004;89:3841
  15. Draper MW, Flowers DE, Huster WJ, Neild JA, Harper KD, Arnaud C. A controlled trial of raloxifene (LY139481) HCl: impact on bone turnover and serum lipid profile in healthy postmenopausal women. J Bone Miner Res. 1996;11:835
  16. Delmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997;337:1641
  17. Harvey HA, Kimura M, Hajba A. Toremifene: an evaluation of its safety profile. Breast. 2006;15:142
  18. Keating NL, O’Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation for prostate cancer. J Clin Oncol. 2006;24:4448
  19. Ellmen J, Hakulinen P, Partanen A, Hayes DF. Estrogenic effects of toremifene and tamoxifen in postmenopausal breast cancer patients. Breast Cancer Res Treat. 2003;82:103
  20. Joensuu H, Holli K, Oksanen H, Valavaara R. Serum lipid levels during and after adjuvant toremifene or tamoxifen therapy for breast cancer. Breast Cancer Res Treat. 2000;63:225

 Study received institutional review board approval at each participating institution.

PII: S0022-5347(07)02303-8

doi: 10.1016/j.juro.2007.08.137

The Journal of Urology
Volume 179, Issue 1 , Pages 152-155 , January 2008

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