Toremifene reduces fractures in PCa

[JimmyToowong]

Editorial - Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer

Written by Christopher P. Evans, MD

Thursday, 11 November 2010

BERKELEY, CA (UroToday.com) - Androgen deprivation therapy (ADT) is used for throughout the prostate cancer (CaP) treatment paradigm. ADT decreases testosterone to castrate levels, but will also decrease serum estradiol levels since estradiol is formed from the peripheral conversion of testosterone by aromatase. Decreased estradiol can negatively impact bone formation and resorption with decreased bone mineral density (BMD) and potentially increased incidence of clinical fractures. In the October 2010 issue of the Journal of Urology, Dr. Matthew Smith and associates report on the use of Toremifene to reduce bone fracture risk in men receiving ADT for CaP. Toremifene is a second-generation selective estrogen receptor modulator (SERM). Is has been shown to increase BMD in patients on ADT. This report evaluated whether toremifene decreased the incidence of new vertebral fractures in men on ADT.

The study was a 2-year, phase III, randomized, double-blind, placebo controlled multicenter international trial. Participants were enrolled 1:1 to 80mg toremifene orally daily or placebo. The participants were men age 50 years or older receiving ADT for CaP at increased risk for fracture based upon age greater than 70 years, or osteopenia at the femoral neck, or L1 to L4 lumbar spine. Exclusion criteria included men who had received a bisphosphonate. Anteroposterior and lateral radiographs of thoracic and lumbar spine and dual energy x-ray absorptiometry of the spine, hip and femoral neck were obtained at baseline, months 12 and 24 or at early study termination. Assessment for vertebral fracture was performed at a central imaging laboratory. A total of 646 men were randomized to toremifene and 638 to placebo. Median age was 76 years and mean ADT exposure at entry was 3.8-4.0 years. Over 92% had serum testosterone in the castrate range.

The 2-year incidence of new vertebral fractures was 4.9% with placebo vs. 2.5% with toremifene, a relative risk reduction of 50%. The risk of all fractures was 10.1% for placebo patients and 6.3% for toremifene patients. BMD increased between 1.9-2.3% in the toremifene group compared with the placebo group. Discontinuation due to a greater than 7% decrease in BMD of the hip or spine occurred in 13 placebo patients (2.8%) compared with 6 toremifene patients (1.3%). Biochemical markers of bone turnover decreased significantly in patients treated with toremifene compared with placebo. Also, beneficial changes in serum lipoproteins were significantly greater in the toremifene treated men. There were no differences in adverse events between the two groups.

Smith MR, Morton RA, Barnette KG, Sieber PR, Malkowicz SB, Rodriguez D, Hancock ML, Steiner MS

J Urol. 2010 Oct;184(4):1316-21

10.1016/j.juro.2010.06.022

PMID: 18398147 Forum: New agents Title: Toremifene reduces fractures in PCa

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