Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of primary hypoparathyroidism
研究概览
简要总结
Observational, multicenter, national, cross-sectional study aiming to describe the epidemiological clinical, biological and therapeutic profile of patients suffering from defect in secretion (hypoparathyroidism) or action (pseudo-hypoparathyroidism) of parathyroid hormone.
详细描述
Endocrinologists from both sectors (public and private) are participating in the study. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypoparathyroidism defined by low serum calcium < 2.2 mmol/l (< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine
排除标准
- •Cervical surgery < 6 months.
- •Transient (neonatal, etc.) or functional (dysmagnesemia, etc.) hypoparathyroidism.
- •Other causes of hypocalcemia: vitamin D deficiency, chronic renal failure, etc.
- •Familial hypocalcemia hypercalciuria.
- •Pseudo-pseudo-hypoparathyroidism.
结局指标
主要结局
Incidence of primary hypoparathyroidism
时间窗: Day 1
Number of subjects with primary hypoparathyroidism at enrollment
Incidence of congenital hypoparathyroidism
时间窗: Day 1
Number of subjects with congenital hypoparathyroidism at enrollment
Incidence of secondary hypoparathyroidism
时间窗: Day 1
Number of subjects with secondary hypoparathyroidism at enrollment
Incidence of acquired hypoparathyroidism
时间窗: Day 1
Number of subjects with acquired hypoparathyroidism at enrollment
次要结局
未报告次要终点