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临床试验/NCT03603444
NCT03603444已完成不适用

Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism

Azienda Ospedaliero-Universitaria di Modena1 个研究点 分布在 1 个国家目标入组 606 人开始时间: 2011年1月1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
606
试验地点
1
主要终点
Serum Calcium to Phosphorus ratio

研究概览

简要总结

BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.

OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.

METHODS: A single-center, retrospective, case-control study will be carried out.

Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.

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
  • HIV-infected patients with reduced phosphorus but normal calcium
  • 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

Professor

Azienda Ospedaliero-Universitaria di Modena

研究点 (1)

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