Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia: an 1-year Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- BMD lumbar spine
研究概览
简要总结
Osteoporosis is a very strong predictor of fractures with low BMD, but more than half of osteoporotic fractures actually occur in the osteopenic patient group. Therefore, it is important to prevent fractures by actively evaluating fracture risk even in patients with osteopenia.
Raloxifene is a second-generation SERM agent that inhibits bone resorption and is used for the prevention and treatment of postmenopausal osteoporosis. The clinical effect of raloxifene has already been demonstrated in the Multiple Outcomes of Raloxifene Evaluation (MORE) study, a large-scale RCT, to increase BMD and improve lipid profile. In this study, we aimed to evaluate the efficacy of Raloxifene plus cholecalciferol in postmenopausal women with osteopenia.
详细描述
Backgroud : Osteoporosis is a powerful predictor of fractures with low BMD, but more than half of osteoporotic fractures occur in osteopenia. Therefore, it is important to start drug treatment after diagnosis of osteoporosis, but it is also important to prevent fractures by actively evaluating the risk of fractures in patients with osteopenia. Raloxifene is a selective oestrogen receptor modulator (SERM) that has beneficial effects on bone and lipid profile and has been approved by the FDA as a treatment to prevent osteoporosis. However, studies on the efficacy of Raloxifene plus cholecalciferol in osteopenia patients lack evidence.
Aim : This study aimed to investigate the efficacy of raloxifene plus cholecalciferol in postmenopausal women with osteopenia.
Methods : A prospective, single-center, randomized, opne label, parallel, intervention study in 112 patients investigating the difference in bone mineral density between raloxifene plus cholecalciferol group and cholecalciferol group. Study participants are randomly assigned using the R procedure in a 1:1 ratio at enrollment. Each participant takes raloxifene plus cholecalciferol or cholecalciferol for 48 weeks. All participants were tested for bone turnover markers, routine chemistry, and lipid profile at baseline and 6-month intervals. In addition, at baseline and 48 weeks, DXA, whole spine x-ray, quantitative CT, bioimpedance analysis, muscle function test (handgrip test, jump power), and EQ-5D test.
Perspectives : More than half of osteoporotic fractures occur in patients with osteopenia. This study will confirm the effect of Raloxifene plus cholecalciferol on bone density and show changes in muscle function and lipid metabolism. Through this, early and active treatment can be suggested as a new guideline for preventing osteoporosis and osteoporotic fractures in postmenopausal women with osteopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (defined as no menstruation for more than 48 weeks prior to screening and no other pathological or physiological causes. If in doubt, a serum follicle-stimulating hormone (FSH) test may be performed at screening)
- •Osteopenia ( -2.5 SD< T-score < -1.0 SD in DXA )
排除标准
- •Secondary osteoporosis (Systemic glucocorticoid use, aromatase inhibitor, thyrotoxicosis, hypeparathyroidism, etc)
- •Vitamin D deficiency at baseline (25-OH-vitD <10ng/mL)
- •Active cancer treatment
- •History of vascular thrombosis
- •Bisphosphonate treatment within the last 12months
- •Contraindication for Raloxifene according to the SPC
研究组 & 干预措施
Raloxifen plus cholecalciferol
Raloxifene 60mg + Cholecalciferol 800 IU
干预措施: Raloxifene plus cholecalciferol (Drug)
Cholecalciferol
Cholecalciferol 800 IU
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
BMD lumbar spine
时间窗: 48 weeks
Change in lumbar spine BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
次要结局
- BMD femoral neck and total hip(48 weeks)
- Bone turnover marker(24 weeks, 48 weeks)
- Muscle function(24 weeks, 48 weeks)
- Lipid profile(24 weeks, 48 weeks)
- Quantitative CT(48 weeks)
- EQ-5D test(24 weeks, 48 weeks)
- Vertebral fracture(48 weeks)
- Bioimpedance analysis(24 weeks, 48 weeks)