Toremifene Citrate increases Bone Mineral Density
Interesting study that just joins the pile of reasons why toremifene citrate is todays superior SERM.
Abstract:
Background: Androgen deprivation therapy decreases bone mineral density and increases fracture incidence. In a recently completed two-year randomized controlled trial of 1382 men, toremifene increased BMD and decreased vertebral fracture incidence in men receiving ADT for prostate cancer. We now describe the effects of toremifene on BMD in various subject subgroups. Methods: We conducted a randomized double blind placebo controlled trial in 1382 men with histologically confirmed prostate cancer on ADT. Key entry criteria included age ≥ 50 years, continuous ADT for 6 months or longer or intermittent ADT for 12 months or longer. Subjects on intermittent ADT at enrollment had to remain on continuous ADT for the duration of their time on study. Subjects were randomized to receive either 80mg toremifene citrate daily or matching placebo. The primary end point was the incidence of new morphometric vertebral fractures. Secondary endpoints included BMD, clinical fragility fractures, bone turnover markers, lipid profile, hot flashes, and gynecomastia. Results: In the overall study population, toremifene increase BMD of the hip and lumbar spine by 1.6% and 2% after two years compared to placebo. Similar beneficial effects of toremifene were observed in each of the subgroups (Table). Conclusions: Toremifene significantly increases bone mineral density of the hip and spine in every subgroup including those men who were older or had prevalent vertebral fractures, longer exposure to ADT, or lower baseline BMD.
K. A. Veverka, B. Malkowicz, M. Smith, R. A. Morton, M. S. Steiner; GTx, Inc., Memphis, TN; University of Pennsylvania, Philadelphia, PA; Massachusetts General Hospital, Boston, MA
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