Study: Bazedoxifene Prevents Postmenopausal Osteoporosis

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.