Abstract | BACKGROUND: OBJECTIVE: To evaluate a Phase III trial of a new SERM, arzoxefine, for prevention of osteoporosis in younger postmenopausal women. METHODS/RESULTS:
Arzoxifene induced modest but significant increases in bone mineral density versus a control group during 2 years of therapy, with minor adverse events. However, fracture efficacy and other patient-specific outcomes were not evaluated. CONCLUSION: Despite a positive study of surrogate end points (bone density and biochemical markers of bone turnover), arzoxifene was withdrawn from further FDA evaluation, principally because of long-term side effects and lack of non-vertebral fracture efficacy in the companion Phase III fracture study. Each SERM has a unique profile on bone and other tissues. Regulatory approval of this class of agents may remain problematic for the immediate future.
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Authors | Francisco J A de Paula, Clifford J Rosen |
Journal | Expert opinion on pharmacotherapy
(Expert Opin Pharmacother)
Vol. 11
Issue 5
Pg. 867-9
(Apr 2010)
ISSN: 1744-7666 [Electronic] England |
PMID | 20113199
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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