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临床试验/NCT03747029
NCT03747029已完成不适用

Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study

Azienda Ospedaliero-Universitaria di Modena1 个研究点 分布在 1 个国家目标入组 1,038 人开始时间: 2017年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,038
试验地点
1
主要终点
Serum Calcium to Phosphorus ratio

研究概览

简要总结

Primary hyperparathyroidism (PHPT) and Hypoparathyroidism (HP) are two of the most frequent disorder of Calcium-Phosphorus (Ca-P) metabolism. The Ca/P ratio is an accurate tool to differentiate patients with PHPT from healthy subjects, according to a previous single-centre study. The reliability of this index is based on the fact that serum Ca and P are inversely related together either in healthy subjects or in patients with PHPT and HP.

详细描述

The aim of this study is to investigate the accuracy and diagnostic value of Ca/P ratio in the diagnosis of primary hyperparathyroidism and hypoparathyroidism. The definition of a valid cut-off of serum Ca/P ratio for patients with these disorders will be of help especially in those patients with apparently normal biochemical profile, but suggestive for primary hyperparathyroidism and hypoparathyroidism.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diagnosis of primary hyperparathyroidism
  • patients with diagnosis of hypoparathyroidism
  • subjects with normal Calcium-Phosphorus metabolism
  • Exclusion Criteria for both cases and controls will be:
  • age younger than 18 or older than 90 years
  • severe renal and liver diseases (i.e. glomerular filtration rate (GFR) <30 ml/min)
  • hyperparathyroidism secondary to Vitamin D deficiency
  • active metabolic bone disease (e.g. Paget's disease of the bone, osteomalacia, rickets, etc)
  • any type of cancer
  • malnutrition
  • severe obesity (BMI > 40 kg/m2)
  • a history of gastrointestinal malabsorption
  • sarcoidosis
  • hypercortisolism
  • diabetes insipidus
  • hyperthyroidism
  • pseudohypoparathyroidism
  • familial hypocalciuric hypercalcemia (FHH)
  • treatment with steroids, active forms of vitamin D (calcitriol, ergocalciferol, etc), thiazides, phosphate binders, lithium, cinacalcet, bisphosphonates, and denosumab.

排除标准

  • 未提供

结局指标

主要结局

Serum Calcium to Phosphorus ratio

时间窗: Assessed only once at the diagnosis (from January 2005 to January 2018)

Calculated formula (serum calcium to serum phosphorus ratio)

次要结局

  • Serum Calcium(Assessed only once at the diagnosis (from January 2005 to January 2018))
  • Serum Phosphorus(Assessed only once at the diagnosis (from January 2005 to January 2018))
  • Serum Parathormone(Assessed only once at the diagnosis (from January 2005 to January 2018))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincenzo Rochira

Associate Professor

Azienda Ospedaliero-Universitaria di Modena

研究点 (1)

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