Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
研究概览
简要总结
This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.
The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are under the age of 75 and are postmenopausal.
- •Individuals diagnosed with osteopenia or osteoporosis, exhibiting a T-score ranging from -3.0 to -1.
- •Patients with hypercholesterolemia starting pitavastatin for the first time.
- •Patients exhibiting baseline bone resorption markers, specifically C-telopeptide levels of 0.300 ng/mL or above, or NTX levels above 16.5 nmolBCE/L.
排除标准
- •Patients who have used a statin medication for more than one month within the last 3 months.
- •Patients who have used oral or injectable glucocorticoids for more than one week within the last 3 months.
- •Patients currently using thiazolidinediones, a class of oral antidiabetic medications.
- •Patients undergoing treatment for malignant tumors.
研究组 & 干预措施
Pitavastatin
Pitavastatin 2 mg or 4 mg once daily
* The dosage is determined based on cholesterol levels and the physician's decision.
干预措施: Pitavastatin (Drug)
结局指标
主要结局
Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
时间窗: 6 month
nmol BCE/L
次要结局
- Change in blood Procollagen Type 1 N-Terminal Propeptide levels(6 and 12 months)
- Change in blood C-Telopeptide of Type I Collagen levels(6 and 12 months)
- Change in blood Osteocalcin levels(6 and 12 months)
- Change in urinary N-Telopeptide of Type I Collagen levels(6 and 12 months)
- Change in blood LDL-cholesterol levels(6 and 12 months)
- Change in blood HbA1c levels(6 and 12 months)
- Changes in bone mineral density(12 months)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital