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Effects of arzoxifene on bone, lipid markers, and safety parameters in postmenopausal women with low bone mass
Osteoporosis International, 10/06/09

Downs Jr RW et al. – Arzoxifene suppressed bone turnover and increased BMD. Within the limitations of this study, the endometrial safety profile of arzoxifene appeared similar to that of raloxifene. While no clear dose effect was evident, arzoxifene 20 and 40 mg/day appeared the optimal doses for reducing bone turnover.

Methods

Postmenopausal women with T-score between ?1 and ?2.5 were randomly assigned to daily arzoxifene 5, 10, 20, or 40 mg, raloxifene 60 mg, or placebo
All received daily calcium

Results

Arzoxifene doses significantly reduced osteocalcin (primary endpoint), type 1 collagen C-telopeptide, bone specific alkaline phosphatase, and procollagen type I amino-terminal propeptide versus placebo, and increased lumbar spine BMD
Arzoxifene generally had greater effects on bone turnover and BMD than raloxifene
Arzoxifene decreased cholesterol, LDL cholesterol, and fibrinogen versus placebo
Endometrial thickness change with arzoxifene not significantly different from placebo or raloxifene
No cases of endometrial hyperplasia or adenocarcinoma observed
Adverse event reporting with arzoxifene similar to that with raloxifene, as were hot flush and night sweat reporting

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