Effect of raloxifene on quality of life: a prospective study using the Utian Quality of Life (UQOL) Scale.

OBJECTIVE: The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women. DESIGN: This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint. RESULTS: A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score. CONCLUSION: Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.

Response to oral bisphosphonates in subgroups of younger and older postmenopausal women.

BACKGROUND: Although the effects of bisphosphonates in bone are known for postmenopausal women, it is not known if younger postmenopausal women have a similar response. Furthermore, it is not known if the effects of alendronate and risedronate differ in postmenopausal women in regard to age, specifically in women at or younger than the mean age of natural menopause. Our aim was to examine the effects of two oral bisphosphonates in postmenopausal women by age. METHODS: This was a post-hoc analysis of postmenopausal women <55 or > or =55 years old with low bone mineral density (BMD), randomized to once weekly alendronate 70 mg or risedronate 35 mg for 1 year with 1-year extensions in U.S. and International Fosamax Actonel Comparison Trials. RESULTS: In both age subgroups of postmenopausal women, alendronate produced significantly greater mean BMD increases from baseline than risedronate at hip trochanter, lumbar spine, total hip, and femoral neck. Changes in BMD were not significantly different between younger and older alendronate-treated women, although treatment differences favoring alendronate were numerically greater for younger than older postmenopausal women at all sites. Significantly greater reductions in bone turnover markers also occurred with alendronate vs. risedronate in both subgroups. Tolerability was similar between treatments. CONCLUSIONS: In this post-hoc subgroup analysis of older and younger postmenopausal women receiving alendronate or risedronate, larger treatment differences in BMD gain in younger compared with older women suggest that patient age may affect the relative efficacy of these antiresorptive drugs.