Results of systematic review s and meta-analyses of r and omized controlled trials have shown that both systemic estrogen therapy or hormone therapy ( estrogen combined with a progestin ) are useful to prevent bone loss , and they are the most effective treatment for such climacteric symptoms as hot flushes , sweating , vaginal dryness , and dyspareunia .
The combination of a SERM with estrogen as a tissue selective estrogen complex ( TSEC ) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms .
This combination is particularly interesting from a clinical point of view , taking into account that estrogen alone did not increase breast cancer risk by the Women 's Health Initiative .
TSEC is hypothesized to provide the benefits of estrogen-alone therapy , with an improved tolerability profile because the SERM component can make possible the elimination of progestin .
The conclusion is that effectively , the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women
Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis .
Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition .
Unfortunately , estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer , respectively .
The selective estrogen receptor modulators ( SERMs ) result in positive estrogenic effects on bone , with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms .
The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene ( a third-generation SERM ) in combination with conjugated estrogens in postmenopausal women .
Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis
Objective : The aim of this study was to examine the endometrial , ovarian , and breast safety of bazedoxifene , a novel selective estrogen-receptor modulator , in postmenopausal women at risk for osteoporosis . Methods : Healthy postmenopausal women ( N = 1,583 ; mean age , 57.6 y ) with lumbar spine or femoral neck bone mineral density T scores between −1 and −2.5 and /or other clinical risk factors for osteoporosis were enrolled in a 24-month , phase 3 , r and omized , double-blind , placebo- and active-controlled trial . They received daily treatment with bazedoxifene 10 , 20 , or 40 mg ; placebo ; or raloxifene 60 mg . Reproductive safety assessment s included periodic transvaginal ultrasound measurements of endometrial thickness , ovarian volume , and presence of ovarian cysts ; periodic endometrial biopsies ; and adverse event reporting . Results : Bazedoxifene was not associated with a significant change from baseline in mean endometrial thickness at month 24 . The percentage of participants with a change from baseline in endometrial thickness or endometrial thickness greater than 5 mm at month 24 was similar among groups . There was no consensus diagnosis of endometrial hyperplasia or malignancy in the bazedoxifene or raloxifene groups ; the rates of other histologic findings , including endometrial polyps , were low ( < 5 % ) and similar among groups . No significant between-group differences were found in the change from baseline in ovarian volume , number or size of ovarian cysts , or incidence of ovarian cancer . Reports of breast pain ( < 4 % ) and breast cancer ( < 1 % ) were low and evenly distributed among groups . Conclusion : A favorable endometrial , ovarian , and breast safety profile was found after 2 years of treatment with bazedoxifene in healthy , recently postmenopausal women at risk for osteoporosis
Results of systematic review s and meta-analyses of r and omized controlled trials have shown that both systemic estrogen therapy or hormone therapy ( estrogen combined with a progestin ) are useful to prevent bone loss , and they are the most effective treatment for such climacteric symptoms as hot flushes , sweating , vaginal dryness , and dyspareunia .
The combination of a SERM with estrogen as a tissue selective estrogen complex ( TSEC ) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms .
This combination is particularly interesting from a clinical point of view , taking into account that estrogen alone did not increase breast cancer risk by the Women 's Health Initiative .
TSEC is hypothesized to provide the benefits of estrogen-alone therapy , with an improved tolerability profile because the SERM component can make possible the elimination of progestin .
The conclusion is that effectively , the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women
Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis .
Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition .
Unfortunately , estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer , respectively .
The selective estrogen receptor modulators ( SERMs ) result in positive estrogenic effects on bone , with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms .
The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene ( a third-generation SERM ) in combination with conjugated estrogens in postmenopausal women .