OASIS-3 Trial and Bone Mineral Density Subanalysis: Design, Methods, and End Points
An expert discusses how the OASIS-3 trial was designed as a 52-week placebo-controlled study in postmenopausal women with moderate to severe vasomotor symptoms, including experimental bone health end points.
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The OASIS-3 trial was a comprehensive 52-week, placebo-controlled, randomized clinical trial specifically designed to evaluate elinzanetant in postmenopausal women experiencing moderate to severe vasomotor symptoms, including hot flashes and night sweats. The study's primary end point focused on vasomotor symptom frequency at week 12, providing robust data on treatment efficacy.
Importantly, the trial included an experimental set of bone health end points evaluated at 52 weeks, representing a significant advancement in understanding the broader health implications of neurokinin receptor antagonists. This dual focus on symptom management and bone health reflects the growing recognition that effective menopausal treatments should address multiple aspects of women's health.
The trial's methodology and extended duration allowed researchers to assess both short-term symptom relief and longer-term bone health outcomes, providing valuable insights into the potential multifaceted benefits of this novel therapeutic approach. This comprehensive study design sets a new standard for evaluating treatments in postmenopausal women.
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