MRI Determination of Femoral Neck Cortical Porosity in Chronic Kidney Disease Metabolic Bone Disease (CKD-MBD)

Investigating Bone Fracture Risk in Chronic Kidney Disease Using Magnetic Resonance Imaging (MRI)

Recruiting
21 years - 50 years
All
1 Location

Brief description of study.

The purpose of this study is to help physicians predict bone fractures in patients with chronic kidney disease (CKD). Patients with kidney failure have an increased risk of hip fractures. Unfortunately, the bone density scans normally used in osteoporosis do not predict these fractures very well. However, new Magnetic Resonance Imaging (MRI) methods have been developed that help identify the amount of water in bone. Bone has two main types of water: (1) water that is attached to the bone itself and (2) water that sits in the normal tiny holes inside the bone. This is important because patients with chronic kidney disease often have large pores (or holes) in their bones that get filled with more of the second type of bone water. Using these MRI methods, a ratio has been developed to estimate how much water is sitting in holes compared to how much water is attached to the bone. This ratio is called the porosity index.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Kidney Disease
  • Age: 21 years - 50 years
  • Gender: All

Inclusion Criteria: 

Chronic Kidney Disease Subjects:
Men and women aged 21-50 years old of any ethnicity.
Severe chronic kidney disease (CKD) defined as stage 4 CKD (eGFR 15-29 ml/min), based on one of the last two measures done in the kidney clinic in the past year
Parathyroid hormone (PTH) values greater than 70 pg/mL, which will be determined by one of the last two laboratory data obtained in the past year.
Agrees to participate in the FIT study (IRB # 1707550885).

Healthy Controls:
Men and women matched by age (within 10 years), ethnicity, diabetes mellitus status (present or absent), and BMI (within 5 points).
No diagnosis or evidence of CKD.
Agrees to participate in the FIT study (IRB # 1707550885).

Healthy Subjects for MRI protocol development only (up to 4):
Men and women aged 21-50 years old of any ethnicity.

Exclusion Criteria: 

Chronic Kidney Disease Subjects:
Treatment with chronic corticosteroids of more than 5 mg/day.
Treatment with calcitriol 
Pregnancy.
MRI contraindication.
Subject does not agree to participate in the FIT core study.

Healthy Controls:
Treatment with chronic corticosteroids of more than 5 mg/day.
Pregnancy.
MRI contraindication.
Subject does not agree to participate in the FIT core study.

Healthy Subjects for MRI protocol development only (up to 4):
Contraindication to MRI

Updated on 19 Feb 2024. Study ID: 1903118532

This study investigates the risk of bone fractures in patients with chronic kidney disease (CKD). People with kidney failure often have a higher chance of hip fractures, but usual bone scans don't predict these well. New MRI methods have been developed to study the water in bones, which is important for understanding bone health. Bone contains two types of water: one that is part of the bone and another that fills small holes in the bone. In CKD patients, these holes may be larger and filled with more water. The study uses a measure called the porosity index to estimate the water in these holes compared to the water attached to the bone.

Participants will undergo MRI scans to measure the porosity index. This involves using MRI technology to see how much water is in the bone and how much is in the holes of the bone. By comparing these measurements, researchers hope to better understand the risk of fractures in people with CKD.

  • Who can participate: Men and women aged 21-50 years with severe chronic kidney disease (stage 4 CKD) or healthy controls matched by age, ethnicity, diabetes status, and BMI can participate.
  • Study details: Participants will undergo MRI scans to measure bone water content. Healthy participants will assist in developing the MRI protocol.

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