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Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women
Cummings, Steven R. McClung, Michael R. Reginster, Jean-Yves Cox, David Mitlak, Bruce Stock, John Amewou-Atisso, Messan Powles, Trevor Miller, Paul Zanchetta, Jose Ruben
Cummings, Steven R.
McClung, Michael R.
Reginster, Jean-Yves
Cox, David
Mitlak, Bruce
Stock, John
Amewou-Atisso, Messan
Powles, Trevor
Miller, Paul
Zanchetta, Jose Ruben
Abstract
Arzoxifene is a selective estrogen receptor modulator (SERM) that has been shown to be more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. In a randomized, blinded trial, women aged 60 to 85 years with osteoporosis, defined as a femoral neck or lumbar spine bone mineral density T-score of −2.5 or less or a vertebral fracture, and women with low bone mass, defined as a bone density T-score of −1.0 or less and above −2.5, were assigned to arzoxifene 20 mg or placebo daily. The primary endpoints were new vertebral fracture in those with osteoporosis and invasive breast cancer in the overall population. After 3 years, the cumulative incidence of vertebral fractures in patients with osteoporosis was 2.3% lower in the arzoxifene group than in the placebo group, a 41% relative risk reduction [95% confidence interval (CI) 0.45–0.77, p < .001]. In the overall population, the cumulative incidence of invasive breast cancer over 4 years was reduced by 1.3%, with a 56% relative reduction in risk (hazard ratio = 0.44, 95% CI 0.26–0.76, p < .001); there was no significant decrease in nonvertebral fracture risk. Arzoxifene increased the cumulative incidence of venous thromboembolic events by 0.7%, with a 2.3-fold relative increase (95% CI 1.5–3.7). Like other SERMs, arzoxifene decreased vertebral fractures and invasive breast cancer while the risk of venous thromboembolic events increased.
Keywords
osteoporosis, fracture, vertebral fracture, breast cancer, arzoxifene, serms, randomized, controlled trial
Date
2011
Type
Journal article
Journal
Journal of Bone and Mineral Research
Book
Volume
26
Issue
2
Page Range
397-404
Article Number
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
DOI
Source URL
Event URL
Open Access Status
License
File Access
Controlled