Chronic Kidney Disease-Mineral and Bone DisorderNCT04564924
To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI
An observational study of Chronic Kidney Disease-Mineral and Bone Disorder, run by Tongji Hospital at 1 site in China.
Trial summary
Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease-Mineral and Bone Disorder
- What is being tested?
- DXA
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject group:Hospitalized patients in department of Nephrology, Tongji Hospital, Qiaokou District, Wuhan, Hubei, China control group:social recruitment
Who may be able to join
- CKD patients aged 18-70 years with free movement
- -
Who cannot join
- The following diseases: rickets, osteomalacia, Paget's disease, acromegaly, scurvy (vitamin C deficiency), hyperthyroidism, history of malignant tumors, received radiotherapy and chemotherapy, fractures within 6 months, lumbar and calf trauma surgery, scoliosis, rheumatic immunity disease, anorexia nervosa, motor neuron disease
- Treated with the following drugs within two years:
- Bisphosphonates: Alendronate , etidronate , Ibandronate, rithiadronate, and zoledronate B) Steroid hormones: estrogen replacement agents , isoflavone derivatives , estrogen, progesterone C) Oral glucocorticoids: prednisone , Prednisone D) Salmon calcitonin
- MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
yan Xiong, PhD, 15549460070 ext. 027, 313857231@qq.com
About this study
Official title: To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI
Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
Read the detailed description
Chronic Kidney Disease-Mineral and Bone Disorder (MBD） is a common complication of chronic kidney disease (CKD), which may lead to defective mineralization, altered bone morphology, and/or bone turnover. Animal research found that bone changes occur even in the early stage of CKD , and with CKD progression, the patient may show symptoms such as bone pain, joint pain, bone deformation, and even spontaneous fractures.
Despite significant advances in understanding bone disease in CKD, most clinical and biochemical targets used in clinical practice remain controversial, resulting in an undermanagement of bone fragility.Our ability to diagnose CKD-MBD and to initiate strategies that could prevent fractures remains limited by the lack of accurate and noninvasive diagnostic tools.
The purpose of this study is to develop a non-invasive method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
- Being tested
- DXA
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXARadiation
Bone mineral density was examined in all cases and controls
| Study group | Role | What they receive |
|---|---|---|
| MRI & DXA patients | No intervention Receives: Radiation: DXA | |
| MRI & DXA volunteers | No intervention Receives: Radiation: DXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance examination for general diagnosis：routine imaging sequences
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.
Measured: 12 months
Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence:Diffusion Weighted Imaging(DWI)-related sequence
Measured: 12 months
Magnetic resonance examination to measure material changes in tissue：CEST
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence: chemical exchange saturation transfer(CEST)
Measured: 12 months
Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence：iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL) - intelligent quantification (IQ)
Measured: 12 months
Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group. And the full abbreviation of the above sequence: ultrashort echo time (UTE)
Measured: 12 months
Magnetic resonance examination for bone morphological observation: ZTE
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group.And the full abbreviation of the above sequence: Zero-Echo Time(ZTE)
Measured: 12 months
Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group. And the full abbreviation of the above sequence: Susceptibility-weighted Imaging(SWI)
Measured: 12 months
Bone mineral density（BMD）measured by DXA
The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.
Measured: 12 months
Blood biochemistry ：Routine blood was used to detect anemia
Routine blood samples were collected from individuals in the experimental group
Measured: 12 months
Blood biochemistry ：renal function was used for staging CKD
Renal function samples were collected from individuals in the experimental group and control group
Measured: 12 months
Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes
Serum electrolyte samples were collected from individuals in the experimental group
Measured: 12 months
Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism
The above serum samples were collected from individuals in the experimental group
Measured: 12 months
Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes
Blood glucose samples were collected from individuals in the experimental group
Measured: 12 months
Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions
CK samples were collected from individuals in the experimental group
Measured: 12 months
The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria
The Routine urine samples were collected from individuals in the experimental group and control group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start2 Sep 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-Mineral and Bone DisorderStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yan Xiong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564924
- Sponsor's protocol ID
- S094
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI
- ClinicalTrials.gov ID
- NCT04564924
- Acronym / sponsor ID
- S094
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
Detailed description
Chronic Kidney Disease-Mineral and Bone Disorder (MBD） is a common complication of chronic kidney disease (CKD), which may lead to defective mineralization, altered bone morphology, and/or bone turnover. Animal research found that bone changes occur even in the early stage of CKD , and with CKD progression, the patient may show symptoms such as bone pain, joint pain, bone deformation, and even spontaneous fractures.
Despite significant advances in understanding bone disease in CKD, most clinical and biochemical targets used in clinical practice remain controversial, resulting in an undermanagement of bone fragility.Our ability to diagnose CKD-MBD and to initiate strategies that could prevent fractures remains limited by the lack of accurate and noninvasive diagnostic tools.
The purpose of this study is to develop a non-invasive method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI & DXA patients | – | Radiation: DXANo intervention |
| MRI & DXA volunteers | – | Radiation: DXANo intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject group:Hospitalized patients in department of Nephrology, Tongji Hospital, Qiaokou District, Wuhan, Hubei, China control group:social recruitment
Key inclusion criteria (2 listed)
- CKD patients aged 18-70 years with free movement
- -
Key exclusion criteria (4 listed)
- The following diseases: rickets, osteomalacia, Paget's disease, acromegaly, scurvy (vitamin C deficiency), hyperthyroidism, history of malignant tumors, received radiotherapy and chemotherapy, fractures within 6 months, lumbar and calf trauma surgery, scoliosis, rheumatic immunity disease, anorexia nervosa, motor neuron disease
- Treated with the following drugs within two years:
- MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXABone mineral density was examined in all cases and controls | Radiation | MRI & DXA patients, MRI & DXA volunteers |
Primary outcome
Magnetic resonance examination for general diagnosis：routine imaging sequences
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.
Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence:Diffusion Weighted Imaging(DWI)-related sequence
Magnetic resonance examination to measure material changes in tissue：CEST
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence: chemical exchange saturation transfer(CEST)
Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence：iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL) - intelligent quantification (IQ)
Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group. And the full abbreviation of the above sequence: ultrashort echo time (UTE)
Magnetic resonance examination for bone morphological observation: ZTE
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group.And the full abbreviation of the above sequence: Zero-Echo Time(ZTE)
Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI
Time frame: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group. And the full abbreviation of the above sequence: Susceptibility-weighted Imaging(SWI)
Bone mineral density（BMD）measured by DXA
Time frame: 12 months
The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.
Blood biochemistry ：Routine blood was used to detect anemia
Time frame: 12 months
Routine blood samples were collected from individuals in the experimental group
Blood biochemistry ：renal function was used for staging CKD
Time frame: 12 months
Renal function samples were collected from individuals in the experimental group and control group
Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes
Time frame: 12 months
Serum electrolyte samples were collected from individuals in the experimental group
Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism
Time frame: 12 months
The above serum samples were collected from individuals in the experimental group
Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes
Time frame: 12 months
Blood glucose samples were collected from individuals in the experimental group
Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions
Time frame: 12 months
CK samples were collected from individuals in the experimental group
The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria
Time frame: 12 months
The Routine urine samples were collected from individuals in the experimental group and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease-Mineral and Bone Disorder, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yan Xiong, PhD (15549460070 ext. 027, 313857231@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance examination for general diagnosis：routine imaging sequences (time frame: 12 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.