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 .
Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study
Summary In this 2-year extension of a 3-year study , bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women .  Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated . Introduction This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years . Methods A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year , r and omized , double-blind , placebo-controlled , phase 3 trial . In the core study ( N = 7,492 ) , subjects received bazedoxifene 20 or 40 mg/day , raloxifene 60 mg/day , or placebo . The raloxifene arm was discontinued after 3 years ; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years . Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo . Endpoints included incidence of new vertebral fractures ( primary ) and non-vertebral fractures , and changes in bone mineral density ( BMD ) and bone turnover markers . Results At 5 years , the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg ( 4.5 % ) and 40/20 mg ( 3.9 % ) versus placebo ( 6.8 % ; P < 0.05 ) , with relative risk reductions of 35 % and 40 % , respectively . Non-vertebral fracture incidence was similar among groups . In a subgroup of higher-risk women ( n = 1,324 ; femoral neck T-score ≤−3.0 and /or ≥1 moderate or severe or ≥2 mild vertebral fracture[s ] ) , bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo ( 37 % ; P = 0.06 ) ; combined data for bazedoxifene 20 and 40/20 mg reached statistical significance ( 34 % reduction ; P < 0.05 ) . Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo ( P < 0.05 ) and was generally safe and well tolerated . Conclusions The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women
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 .