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The safety and tolerability profile of therapies for the prevention and treatment of osteoporosis in postmenopausal women

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References

  • Papers of interest = *
  • Papers of particular interest= **
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**Clinical recommendations for preventing and treating osteoporosis in postmenopausal women and men >50 years, developed by a multispecialty council of experts on bone health

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*After reviewing studies published since 2010, the task force concludes that atypical femur fractures are stress or insufficiency fractures and provides a revised case definition listing clinical characteristics of these fractures

*The AAOM changes “bisphosphonate-related osteonecrosis of the jaw” to “medication-related osteonecrosis of the jaw” (MRONJ) in recognition that other antiresorptive and antiangiogenic therapies have also been associated with ONJ. This paper also provides risk estimates of MRONJ; discusses risk/benefits of associated medications; and provides guidance as to differential diagnosis, prevention and management of MRONJ

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**Meta-analysis of 10 denosumab trials, including FREEDOM, suggesting a borderline increased risk of serious infections (RR=1.23, 95% CI, 1.00-1.52)

*EMA Assessment of benefits and risks of strontium ranelate, including risks of VTE, DRESS, Stevens-Johnson syndrome, and toxic epidermal necrolysis in strontium ranelate users

**A recent summary of findings during the intervention and extended (median, 13 years) postintervention phases of both randomized Women’s Health Initiative trials. This paper synthesizes results for primary, secondary, and quality of life outcomes, and also provides results for some outcomes stratified by age or time since menopause

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**The second 2-year extension of the core 3-year bazedoxifene trial supports sustained efficacy (vertebral fracture reduction) and favorable safety/tolerability of bazedoxifene for 7 years in postmenopausal women with osteoporosis

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**One of several publications from the phase 3 SMART-5 trial of conjugated estrogens/bazedoxifene, this paper demonstrates improvements in lumbar spine and total hip BMD, a low (<1%) rate of endometrial hyperplasia, and lower rates of vaginal bleeding and breast tenderness compared with conjugated estrogens/medroxyprogesterone acetate

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