Um Mi Jung, Cho Eun A, Jung Hyuk
Department of Obstetrics and Gynecology, Chosun University Hospital, Gwangju, Korea.
Department of Nursing, Honam University, Gwangju, Korea.
J Menopausal Med. 2017 Apr;23(1):56-62. doi: 10.6118/jmm.2017.23.1.56. Epub 2017 Apr 28.
To evaluate and compare the efficacy and safety of the combination of raloxifene and alendronate with those of monotherapies in elderly women with osteoporosis.
Sixty-two postmenopausal women (mean age 63.5 ± 0.5 years) attending gynecologic osteoporosis clinics with established osteoporosis were randomly allocated to one of four treatment groups and monitored for 3 years. All patients enrolled in this study, including those in the control group (n = 14), received 1.0 g elemental calcium and 400 units of vitamin D per day. The raloxifene group (n = 16) received raloxifene 60 mg (Evista®) per day; alendronate group (n = 17) received low-dose (5 mg) alendronate with calcitriol 0.5 µg (Maxmarvil®) per day; and the combination therapy group (n = 15) received both raloxifene 60 mg and low-dose (5 mg) alendronate with calcitriol 0.5 µg. Bone mineral density (BMD) was measured in the lumbar spine and hip before and after 3 years of treatment.
In patients who received the combined therapy, BMD increased in the lumbar spine and the hip by 7.2% (<0.001) and 4.8% (<0.001) at 3 years. For patients in the alendronate group, the increases were 6.7% (<0.001) and 3.1% (<0.01) respectively, for the raloxifene group, the increases were 4.36% (<0.001) and 1.9% (<0.05) in the vertebrae and femora, respectively; however, the BMD of patients in the control group decreased by 1.81% (<0.05) and 1.6% (<0.05), respectively, after 3 years. Patients who received the combination therapy had significantly higher BMD in both the vertebrae femora (<0.01) in comparison to that in those treated with raloxifene or alendronate individually.
This 3-year randomized study showed the improved effects of alendronate and raloxifene combination on spine and hip BMD in elderly postmenopausal women with established osteoporosis.
评估并比较雷洛昔芬与阿仑膦酸钠联合用药与单一用药治疗老年骨质疏松女性的疗效和安全性。
62名就诊于妇科骨质疏松门诊且确诊为骨质疏松的绝经后女性（平均年龄63.5±0.5岁）被随机分配至四个治疗组之一，并接受为期3年的监测。本研究纳入的所有患者，包括对照组（n = 14），均每日服用1.0 g元素钙和400单位维生素D。雷洛昔芬组（n = 16）每日服用60 mg雷洛昔芬（易维特®）；阿仑膦酸钠组（n = 17）每日服用低剂量（5 mg）阿仑膦酸钠和0.5 μg骨化三醇（马克马维®）；联合治疗组（n = 15）每日服用60 mg雷洛昔芬以及低剂量（5 mg）阿仑膦酸钠和0.5 μg骨化三醇。在治疗3年前后测量腰椎和髋部的骨密度（BMD）。
接受联合治疗的患者，3年后腰椎和髋部的骨密度分别增加了7.2%（<0.001）和4.8%（<0.001）。阿仑膦酸钠组患者，腰椎和髋部的骨密度分别增加了6.7%（<0.001）和3.1%（<0.01）；雷洛昔芬组患者，椎骨和股骨的骨密度分别增加了4.36%（<0.001）和1.9%（<0.05）；然而，对照组患者3年后腰椎和髋部的骨密度分别下降了1.81%（<0.05）和1.6%（<0.05）。与单独使用雷洛昔芬或阿仑膦酸钠治疗的患者相比，接受联合治疗的患者椎骨和股骨的骨密度均显著更高（<0.01）。
这项为期3年的随机研究表明，阿仑膦酸钠与雷洛昔芬联合用药对确诊为骨质疏松的老年绝经后女性的脊柱和髋部骨密度有更好的改善作用。
