Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Can 18F-PET-CT describe bone formation rate?
研究概览
简要总结
The aim of the study is to
- To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
- To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes
- To investigate if non-oxidized PTH reflects bone turnover
详细描述
Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited.
A bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
- •PTH < 150 pg/ml or PTH > 300 pg/ml
排除标准
- •ongoing malignancy
- •Allergy towards tetracyclin
- •Pregnancy
- •Control Group:
- •Inclusion Criteria:
- •≥ 18 years
- •eGFR >= 60 ml/min
- •under examination for c prostata
- •Prostatic Specific Antigen (PSA) total <40 µg/l
- •Former kidney disease
- •ionized calcium or PTH outside normal range
- •Known metabolic bone disease
- •treatment with anticoagulants
- •Disturbed thrombosis and hemostasis
结局指标
主要结局
Can 18F-PET-CT describe bone formation rate?
时间窗: The bone biopsy and 18F-PET will be performed during two month for each participant
The ROC curve for 18F uptake by bone measured as bone plasma clearance (ki) to descriminate between high and low bone turnover measured as bone formation rate
Can non-oxidized PTH describe bone formation rate?
时间窗: Blood sample and bone biopsy will be performed during two month for each participant
The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate
次要结局
- Can 18F-PET-CT describe mineral apposition rate?(The bone biopsy and 18F-PET will be performed during two month for each participant)
- Can non-oxidized PTH describe mineral apposition rate?(Blood sample and bone biopsy will be performed during two month for each participant)
研究者
Ditte Hansen
Associate professor
Herlev Hospital