Chronic Kidney Disease Requiring Chronic DialysisNCT02616627
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aims: 1. To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients. 2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Osteoporosis
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Feb 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Kidney Disease Requiring Chronic Dialysis
Who may be able to join
- Age >20 years and one of the below
- Chronic hemodialysis
- Chronic peritoneal dialysis
Who cannot join
- 1. get pregnant or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Chutung branch
Hsinchu, 31604
Ding-Cheng Chan, MD,PHD, 886-2-23123456 ext. 67786, doctord6226@yahoo.com
Ding-Cheng Chan, MD,PHD
About this study
Aims:
- To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients.
- To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.
Read more
Method:
In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.
Read the detailed description
Background:
Several large-scale studies enrolling CKD patients discovered that low BMD is still an important risk factor for developing fragility fractures, while chronic dialysis patients are reported to have 4 to5 fold higher risk of fracture compared to general population. However, the relationship between bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and fracture and other adverse events in patients with CKD patients is still unclear. In addition, declining of renal function could affect the normal physiological regulating of blood levels of calcium, phosphate, fibroblast growth factor 23 (FGF23), parathyroid hormone (PTH), and vitamin D, which could influence the bone mineral density of chronic dialysis patients. Recently, it is well known that serum FGF23 is already elevated at the early stage of CKD patients and independently related to CKD. However, there are a limited number of reports indicate that the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients.
Aims:
- To determine whether BMD by DXA was associated with fractures and other adverse events in dialysis patients.
- To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.
Method:
In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes.
Patient characteristics
Inclusion Criteria:
- Age >20 years and one of the below
- Chronic hemodialysis
- Chronic peritoneal dialysis
Exclusion Criteria:
get pregnant or planning a pregnancy
Anticipated results:
- The investigators expect that results and findings discovered from this study could show the effects of interactions of FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients, which should be an important step on improving clinical decision for osteoporosis and fracture risk in renal dialysis patients.
- Publishing results in an academic journal.
- Keywords
- bone mineral density, chronic dialysis, end-stage renal disease, body composition analysis, sarcopenia
- Medical subject headings
- Osteoporosis, Kidney Failure, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic dialysis | Patient enrolled at the National Taiwan University Hospital Jinshan branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density by DXA,
Change of BMD between baseline and one year was measured
Measured: one year
Secondary outcomes (2)
Blood tests
Change of baseline and one year value of various blood tests mentioned in the summary
Measured: one year
Sarcopenia
Changes of saropenia percentage at 6 month and one year compared to baseline assessments. 3 measures were used, muscle mass, grip strength, and walking speed
Measured: baseline, 6 month and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2021
- Study completionFeb 2026 (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 Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case only
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, MD, PhD, Principal investigator, National Taiwan University Hospital, Chutung branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616627
- Sponsor's protocol ID
- 201505154RINB
- Status last verified
- May 2022
- First submitted
- 25 Nov 2015
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
- ClinicalTrials.gov ID
- NCT02616627
- Acronym / sponsor ID
- 201505154RINB
- Keywords
- bone mineral density, chronic dialysis, end-stage renal disease, body composition analysis, sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2021 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- 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.
Aims:
- To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients.
- To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.
Method:
In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.
Detailed description
Background:
Several large-scale studies enrolling CKD patients discovered that low BMD is still an important risk factor for developing fragility fractures, while chronic dialysis patients are reported to have 4 to5 fold higher risk of fracture compared to general population. However, the relationship between bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and fracture and other adverse events in patients with CKD patients is still unclear. In addition, declining of renal function could affect the normal physiological regulating of blood levels of calcium, phosphate, fibroblast growth factor 23 (FGF23), parathyroid hormone (PTH), and vitamin D, which could influence the bone mineral density of chronic dialysis patients. Recently, it is well known that serum FGF23 is already elevated at the early stage of CKD patients and independently related to CKD. However, there are a limited number of reports indicate that the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients.
Aims:
- To determine whether BMD by DXA was associated with fractures and other adverse events in dialysis patients.
- To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.
Method:
In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes.
Patient characteristics
Inclusion Criteria:
- Age >20 years and one of the below
- Chronic hemodialysis
- Chronic peritoneal dialysis
Exclusion Criteria:
get pregnant or planning a pregnancy
Anticipated results:
- The investigators expect that results and findings discovered from this study could show the effects of interactions of FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients, which should be an important step on improving clinical decision for osteoporosis and fracture risk in renal dialysis patients.
- Publishing results in an academic journal.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic dialysis | – | –Patient enrolled at the National Taiwan University Hospital Jinshan branch |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Kidney Disease Requiring Chronic Dialysis
Key inclusion criteria (3 listed)
- Age >20 years and one of the below
- Chronic hemodialysis
- Chronic peritoneal dialysis
Key exclusion criteria (1 listed)
- 1. get pregnant or planning a pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mineral density by DXA,
Time frame: one year
Change of BMD between baseline and one year was measured
2 secondary outcomes
Blood tests
Time frame: one year
Sarcopenia
Time frame: baseline, 6 month and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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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.
Ding-Cheng Chan, MD, PhD principal investigator
National Taiwan University Hospital, Chutung branch
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 Requiring Chronic Dialysis and Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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 4 May 2022. 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 Taiwan. 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 Ding-Cheng Chan, MD, PhD (886-2-23123456 ext. 67786, doctord6226@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density by DXA, (time frame: one year). 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 4 May 2022.