Bazedoxifene Reduces Nonvertebral Fractures in High-Risk Postmenopausal Women With Osteoporosis: Presented at ASBMR

To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Bazedoxifene Reduces Nonvertebral Fractures in High-Risk Postmenopausal Women With Osteoporosis: Presented at ASBMR
URL: http://www.pslgroup.com/dg/22D43E.htm
Doctor's Guide
September 23, 2008

By Louise Gagnon

MONTREAL -- September 18, 2008 -- Treatment with the selective oestrogen receptor-modulator bazedoxifene decreases the risk of nonvertebral fractures in postmenopausal women with osteoporosis at elevated risk for fracture, according to a phase 3 trial involving 200 sites presented here at the American Society of Bone and Mineral Research (ASBMR) 30th Annual Meeting.

"Both doses of bazedoxifene [20 and 40 mg] demonstrated an overall treatment effect," said study investigators Arkadi Chines, MD, PhD, Wyeth Pharmaceuticals, Collegeville, Pennsylvania. "The data suggest the doses are comparable."

The primary endpoint of the study was incidence of new vertebral fractures as assessed through thoracolumbar radiographs after 36 months, explained Dr. Chines in a poster presentation on September 15.

The study enrolled 7,492 women a mean of 66.4 years old and randomly assigned them to 1 of 4 treatment arms: bazedoxifene 20 mg; bazedoxifene 40 mg; raloxifene 60 mg; or placebo. Subjects also received supplementation of vitamin D and calcium.

Previous research has shown that bazedoxifene reduces the risk of new vertebral fractures, but the women in that study had a low overall risk of fractures, explained Dr. Chines.

The women enrolled in this analysis were without prevalent vertebral fractures and had lumbar spine and femoral neck T scores of -2.5 or less. Women with prevalent vertebral fractures were required to have lumbar spine and femoral neck T scores of -4.0 or more.

"For some women, this is secondary prevention, and we are aiming to prevent a second fracture, and for some women it is primary prevention, and we are aiming to prevent a first fracture," said Dr. Chines in an interview.

In a subgroup of 1,772 women at elevated fracture risk with femoral neck T scores of -3.0 or less and/or 1 or more moderate or 2 or more mild vertebral fractures at study entry, rates of nonvertebral fractures were 4.9% with bazedoxifene 20 mg, 6.5% with bazedoxifene 40 mg, 8.4% with raloxifene 60 mg, and 9.1% with placebo.

The 20-mg dose of the bazedoxifene decreased nonvertebral fractures incidence relative to placebo and relative to 60-mg raloxifene (50% and 44%, respectively; P <= .05). When combining nonvertebral fractures data for the 2 bazedoxifene doses, the investigators found a 40% decrease relative to placebo (P = .03).

Bazedoxifene was well tolerated, Dr. Chines said, and noted that adverse effects were no different from those seen with other agents in the same class of drugs, such as increased risk of hot flashes, leg cramps, and thromboembolism, although the incidence of thromboembolism is very low, he added.

The investigators did not observe effects on the endometrium such as endometrial polyps, bleeding, or cancer that were dissimilar to rates that were observed amongst patients on placebo, said Dr. Chines.

The study has been extended to more than 5 years, said Dr. Chines.

Funding for this study was provided by Wyeth Research.

[Presentation title: Efficacy of Bazedoxifene in Reducing the Incidence of Nonvertebral Fractures in Postmenopausal Osteoporotic Women at Higher Fracture Risk. Abstract M390]

http://www.docguide.com

Return to News Story Page

webmaster@pslgroup.com