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 .
Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study.
UNLABELLED Osteoporosis is an increasingly common health concern in postmenopausal women . In a 2-yr phase III study , bazedoxifene prevented bone loss , reduced bone turnover , and was well tolerated in early postmenopausal women with normal or low BMD . INTRODUCTION Bazedoxifene is a novel selective estrogen receptor modulator that has increased BMD and bone strength in experimental models , without stimulating breast or uterus . This 24-mo , r and omized , double-blind study assessed the efficacy and safety of three doses of bazedoxifene compared with placebo and raloxifene in the prevention of postmenopausal osteoporosis . MATERIAL S AND METHODS Healthy postmenopausal women with a BMD T-score at the lumbar spine or femoral neck between -1.0 and -2.5 or clinical risk factors for osteoporosis were r and omly assigned to one of five groups : bazedoxifene 10 , 20 , or 40 mg/d , placebo , or raloxifene 60 mg/d . All women received elemental calcium . Efficacy outcomes included changes from baseline through 24 mo in BMD of the lumbar spine , hip , femoral neck , and femoral trochanter and biomarkers of bone metabolism . RESULTS The intent-to-treat population included 1434 women ( mean age , 58 yr ; mean time from last menstrual period , 11 yr ) . All doses of bazedoxifene and raloxifene prevented bone loss , whereas in the placebo group , there was significant loss of BMD at all skeletal sites . Mean differences in percent change in lumbar spine BMD from baseline to 24 mo relative to placebo were 1.08 + /- 0.28 % , 1.41 + /- 0.28 % , 1.49 + /- 0.28 % , and 1.49 + /- 0.28 % for 10 , 20 , and 40 mg bazedoxifene and 60 mg raloxifene , respectively ( p < 0.001 for all comparisons ) . Comparable BMD responses were observed at other body sites . Significant and comparable decreases in serum osteocalcin and C-telopeptide levels from baseline and relative to placebo with active treatment were observed as early as 3 mo and were sustained through study conclusion ( p < 0.001 ) . Overall incidences of adverse events , serious adverse events , and discontinuations caused by adverse events were similar between groups . The most common adverse events included headache , infection , arthralgia , pain , hot flush , and back pain . CONCLUSIONS Treatment with bazedoxifene prevented bone loss and reduced bone turnover equally as well as raloxifene and was generally well tolerated in postmenopausal women with normal/low BMD
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 .