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| |  Toremifene Shows Promise in Improving Bone Health for Men Receiving Androgen Deprivation Therapy: Presented at ASBMR By John Otrompke DENVER -- September 17, 2009 -- Toremifene, currently used in the treatment of breast cancer, has beneficial effects on the bone health of men undergoing androgen deprivation therapy (ADT) for prostate cancer, but the effects may vary according to patient characteristics, researchers stated here at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR). Toremifene increased total hip bone mineral density (BMD) in all subgroups. However, the increase did not reach statistical significance in Mexican men or men with bilateral orchiectomies, and the effect seemed to be most pronounced in those with low body mass index (BMI). “My guess is the decreased efficacy in Mexican men was because we had less people from those sites,” said Christi Capers, PharmD, GTx, Inc., Memphis, Tennessee. Only about 17 sites enrolled Mexican men in the study, she said on September 14. In the randomised, placebo-controlled trial, 699 men receiving ADT for prostate cancer were assigned to toremifene and 690 were assigned to placebo, and followed for 24 months. The men had been on hormone therapy for at least 6 months. Of those who received the drug, 54% developed osteoporosis, compared with 54.2% in the placebo arm. For osteopenia, 22.1% of those who received toremifene developed the condition, while 27.1% of those on placebo developed osteopenia. Use of the drug was associated with a 53% reduction in new morphometric vertebral fractures. In a modified intent-to-treat group, 4.9% of those on placebo developed fractures, compared with 2.3% of those on the drug. For the group as a whole, the numbers were 3.5% and 1.6%, respectively. The 970 patients in the modified intent-to-treat group received 1 x-ray during the study and were included in efficacy analysis, while a total of approximately 1,382 patients were included in safety analysis, including some who did not receive x-rays. Researchers evaluated the effects of the drug on BMD of the hip and spine according to subgroup. The subgroups analysed included age, race, geographic region, prior ADT, BMI, prevalent vertebral fractures, gonadal steroid levels, and bone-turnover marker levels. In the overall study population, toremifene increased BMD at the lumbar spine by 2.3% over placebo, and by 1.9% at the total hip. Side effects included hot flashes, peripheral oedema, and pain in extremities. There were no significant differences between groups. Funding for this study was provided by GTx, Inc. [Presentation title: Effects of Toremifene 80 mg on Bone Mineral Density in Men Receiving Androgen Deprivation Therapy for Prostate Cancer. Abstract MO0363]
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