期刊
JOURNAL OF BONE AND MINERAL RESEARCH
卷 26, 期 2, 页码 397-404出版社
WILEY
DOI: 10.1002/jbmr.191
关键词
OSTEOPOROSIS; FRACTURE; VERTEBRAL FRACTURE; BREAST CANCER; ARZOXIFENE; SERMS; RANDOMIZED; CONTROLLED TRIAL
资金
- Amgen
- Eli Lilly and Company
- Pfizer
- Novartis
- Merck
- Procter Gamble
- sanofi-aventis
- Servier
- Negma
- Wyeth
- GlaxoSmithKline
- Roche
- Nycomed
- NPS
- Theramex
- Merck Sharp Dohme
- Rottapharm
- IBSA
- Genevrier
- Teijin
- Teva
- Ebewee Pharma
- Zodiac
- Analis
- Novo-Nordisk
- Bristol Myers Squibb
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 20mg 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. (C) 2011 American Society for Bone and Mineral Research.
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