Skeletal Benefits of Two Years of Alendronate Treatment Are Similar for Early Postmenopausal Asian and Caucasian Women

Abstract

Alendronate has been shown to increase bone density among early postmenopausal women. Osteoporosis is common among both Asian and Caucasian women, but most clinical trials have consisted primarily of Caucasian women, and it does not appear that the effectiveness of antiresorptive agents such as alendronate has been compared between the two races. In this study we compared the response of bone density and biochemical markers to alendronate among 136 Asian and 126 Caucasian women who participated in the Early Postmenopausal Interventional Cohort (EPIC) at the Hawaii center. Approximately 40 women of each race were randomly assigned to placebo or to 2.5 mg/day or 5 mg/day alendronate. Bone mineral density (BMD) was measured at the spine, total hip and total body at baseline, 12 months and 24 months; biochemical markers of bone turnover were measured at 6-month intervals. Responses were greater for the 5 mg dose than 2.5 mg, and were similar in the two races. For example, mean (SE) changes in spine BMD at 24 months for Caucasians and Asians, respectively, were -1.9% (0.5%) and -1.9% (0.4%) for the placebo group, 2.0% (0.5%) and 3.4% (0.5%) at 2.5 mg/day and 4.2% (0. 5%) for both races at 5 mg/day. Corresponding changes in urinary N-telopeptide collagen crosslinks were -33.6% (5.6%) and -27.8% (5. 8%) for placebo, -51.4% (4.0%) and -62.1 (4.3%) at 2.5 mg/day and -70.8% (2.4%) and -73.5% (3.1%) at 5 mg/day. We conclude that (1) the rate of bone loss in untreated Asian and Caucasian postmenopausal women is similar, with the possible exception of the hip; (2) 5 mg alendronate daily provides greater skeletal benefits than 2.5 mg/day in both Asian and Caucasian early postmenopausal women; and (3) the response at 5 mg/day is similar in the two races.

Efficacy and safety of bazedoxifene in postmenopausal Asian women

“…Although the baseline characteristics were generally comparable in the two studies, the Asian population in the current study had slightly lower mean BMIs (23.7 vs 25.6 kg/m 2 ) and lumbar spine BMD T-scores (−1.1 vs −1.2) at baseline. The positive effects of bazedoxifene on BMD in the present study were generally similar to those previously observed in osteoporosis prevention studies of raloxifene (1-2% greater than placebo) [13,14,16,17] and somewhat smaller than those seen with bisphosphonates (1.5-4.5% greater than placebo, with high variability between studies) [11,12,[18][19][20] over 6 to 12 months of treatment; these ranges include studies performed in both Caucasian and Asian women. Bazedoxifene was also associated with statistically significant improvements in BMD and bone turnover marker levels in a phase 2 study of Japanese postmenopausal women with osteoporosis [21].…”

“…In addition, the relative fracture risk and cost-effectiveness of treatment have been shown to vary by race and ethnicity [9], which may be the result of genetic differences, such as smaller skeletal sizes and vitamin D receptor polymorphisms [10]. A number of studies have evaluated the efficacy and safety of bisphosphonates [11,12] and the selective estrogen receptor modulator (SERM) raloxifene [13] for the prevention of osteoporosis in postmenopausal Asian women; however, clinical data in this population are limited [10].…”

Effects of alendronate combined with hormone replacement therapy on osteoporotic postmenopausal Chinese women

“…To our knowledge, there are no large-scale studies in regard to ethnic differences in the responses to alendronate treatment. A few studies have indicated that there does not seem to be any difference in the response to alendronate among African Americans and whites or Chinese and whites [27,28]. Nonetheless, the amplitude of treatment responses of Chinese women in our study is similar to or even greater than that reported in other series.…”

Osteonecrosis of the jaw induced by oral administration of bisphosphonates in Asian population: five cases

“…It is well known that this drug is effective irrespective of race [27][28][29][30][31][32][33]. Therefore, we can predict that the side effects from bisphosphonate are also independent of race.…”