Objective To summarize recommended updates to the 2001 Stages of Reproductive Aging Workshop (STRAW) criteria. The 2011 STRAW+10 workshop reviewed advances in understanding of the critical changes in hypothalamic-pituitary-ovarian function that occur before and after the final menstrual period (FMP). Methods Scientists from five countries and multiple disciplines evaluated data from cohort studies of midlife women and in the context of chronic illness and endocrine disorders, on change in menstrual, endocrine and ovarian markers of reproductive aging including anti-mullerian hormone (AMH), inhibin B, follicle-stimulating hormone (FSH), and antral follicle count (AFC). Modifications were adopted by consensus. Results STRAW+10 simplified bleeding criteria for the early and late menopausal transition, recommended modifications to criteria for the late reproductive stage (Stage − 3) and the early post-menopause stage (Stage +1), provided information on the duration of the late transition (Stage −1) and early post-menopause (Stage +1) and recommended application regardless of women’s age, ethnicity, body size or lifestyle characteristics. Conclusion STRAW+10 provides a more comprehensive basis for assessing reproductive aging in research and clinical contexts. Application of the STRAW+10 staging system should improve comparability of studies of midlife women and facilitate clinical decision-making. Nonetheless, important knowledge gaps persist and seven research priorities are identified.

STRAW + 10 provides a more comprehensive basis for assessing reproductive aging in research and clinical contexts. Application of the STRAW + 10 staging system should improve comparability of studies of midlife women and facilitate clinical decision making. Nonetheless, important knowledge gaps persist, and seven research priorities are identified.

ABSTRACT:In this 3-yr, randomized, double-blind, placebo-and active-controlled study, healthy postmenopausal women with osteoporosis (55-85 yr of age) were treated with bazedoxifene 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. The primary endpoint was incidence of new vertebral fractures after 36 mo; secondary endpoints included nonvertebral fractures, BMD, and bone turnover markers. Among 6847 subjects in the intent-to-treat population, the incidence of new vertebral fractures was significantly lower (p < 0.05) with bazedoxifene 20 mg (2.3%), bazedoxifene 40 mg (2.5%), and raloxifene 60 mg (2.3%) compared with placebo (4.1%), with relative risk reductions of 42%, 37%, and 42%, respectively. The treatment effect was similar among subjects with or without prevalent vertebral fracture (p ‫ס‬ 0.89 for treatment by baseline fracture status interaction). The incidence of nonvertebral fractures with bazedoxifene or raloxifene was not significantly different from placebo. In a posthoc analysis of a subgroup of women at higher fracture risk (femoral neck T-score Յ -3.0 and/or Ն1 moderate or severe vertebral fracture or multiple mild vertebral fractures; n ‫ס‬ 1772), bazedoxifene 20 mg showed a 50% and 44% reduction in nonvertebral fracture risk relative to placebo (p ‫ס‬ 0.02) and raloxifene 60 mg (p ‫ס‬ 0.05), respectively. Bazedoxifene significantly improved BMD and reduced bone marker levels (p < 0.001 versus placebo). The incidence of vasodilatation, leg cramps, and venous thromboembolic events was higher with bazedoxifene and raloxifene compared with placebo. In conclusion, bazedoxifene significantly reduced the risk of new vertebral fracture in postmenopausal women with osteoporosis and decreased the risk of nonvertebral fracture in subjects at higher fracture risk.

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