The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- changes in Parathyroid hormone levels
研究概览
简要总结
This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related fractures.
Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. Patients with heartburn will be assigned to the intervention group and will be assigned to take a PPI for three months. Healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling.
Levels of biochemical markers in the two groups will be compared using two-way analysis of variance (ANOVA). Changes in biochemical parameters within a group will be assessed using repeated measures ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18-50 years
- •Healthy (or healthy with heartburn only)
排除标准
- •Female gender
- •Previous allergy to PPI
- •Regular beach seekers (more than once a week)
- •Intestinal disease
- •Recent fracture (within the past six months)
- •Kidney stones
- •Intake of the following medications:
- •Vitamin D or calcium supplements
- •PPIs or H2 receptor antagonists within the past year
- •One-Alpha
- •Anticonvulsants
- •Glucocorticoids
研究组 & 干预措施
Proton Pump Inhibitors
patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)
干预措施: Rabeprazole or Esomeprazole or Lanzoprazole (Drug)
结局指标
主要结局
changes in Parathyroid hormone levels
时间窗: baseline and 3 months
PTH levels at 3 months minus at baseline
次要结局
- changes in 25-OH-Vitamin D blood levels(baseline and 3 months)
- changes in osteocalcin levels in blood(baseline and 3 months)
- changes in crosslaps levels in blood(baseline and 3 months)
- changes in serum ionized calcium levels(baseline and 3 months)
研究者
Ala'a Sharara
Professor
American University of Beirut Medical Center