The Effectiveness of Rapid correction versus Gradual correction in cases of vitamin D deficient Osteoporotic patients- A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in T-score on DEXA scan of right hip from baseline to 6 months.
研究概览
简要总结
this study evaluates the effectiveness of rapid versus gradual vitamin D correction in osteoporotic patients above 50 years of age with hypovitaminosis D. Osteoporosis is a condition of reduced bone mass and increased fracture risk, commonly diagnosed by DEXA scan. Standard therapy includes bisphosphonates, calcium, and vitamin D supplementation. However, the optimal method of vitamin D correction remains unclear. This randomized controlled trial will include 76 participants divided into two groups. The control group will receive bisphosphonates, 2000 IU/day vitamin D, and calcium, while the treatment group will receive the same regimen plus 60000 IU vitamin D daily for 5 days to achieve rapid correction. Serum vitamin D will be measured at baseline, day 6, and 6 months, while DEXA scans will be repeated at 6 months. Exclusion criteria include secondary osteoporosis, renal failure, endocrine disorders, and malignancy. Data will be analyzed using SPSS with t tests and chi square tests, with significance set at p less than 0.05. The primary outcome is change in DEXA scores between the two groups, while secondary outcomes include correlation between DEXA and vitamin D levels. The study aims to provide evidence on whether rapid correction offers superior bone health benefits compared to gradual correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients who had given consent for the study.
- •2.Patients of age between more than 50 years with osteoporosis (T score less than -2.5 SD) as determined by DEXA scan.
- •3.Patients with normal Sr Creatinine, Sr Calcium, Sr Phosphate, Sr Alkaline Phosphatase.
排除标准
- •Secondary osteoporosis due to utilization of drugs like phenytoin, warfarin, corticosteroids etc and disuse osteoporosis due to deformity or stiffness or patients with endocrinological disorders causing osteoporosis.
- •Patients with abnormally high Sr Parathyroid levels with hypercalcemia ( primary hyperparathyroidism causes.
- •secondary osteoporosis)
- •Subjects with vitamin D level more than 30ng/dL.
- •HIV patients using ART.
- •Patients with active tuberculosis or patients on anti-tubercular treatment.
- •Renal Failure patients on dialysis or post transplantation or patients with high serum creatinine.
- •Subjects with history of nephrolithiasis, urolithiasis.
- •Elderly women using hormone replacement therapy.
- •Elderly men using testosterone inhibitors for BPH.
- •Patients with sarcoidosis or malignancies or chemotherapy.
- •Alcoholic liver disease or any other significant liver disease with elevated enzymes.
- •Malabsorption syndromes.
- •Rheumatological disorders on DMARDs.
结局指标
主要结局
Change in T-score on DEXA scan of right hip from baseline to 6 months.
时间窗: Baseline and 6 months
Change in serum 25-hydroxy Vitamin D levels from baseline to 6 months.
时间窗: Baseline and 6 months
Proportion of patients achieving Vitamin D sufficiency at 6 months.
时间窗: Baseline and 6 months
次要结局
未报告次要终点