Renal OsteodystrophyNCT00859612
Renal Osteodystrophy: A Fresh Approach
An observational study of Renal Osteodystrophy, run by Hartmut Malluche, MD at 1 site in United States.
Trial summary
There are two major goals of this project: 1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Osteodystrophy
- How many people
- 464 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from dialysis clinics
Who may be able to join
- Aged 18 years or older;
- Chronic maintenance dialysis of at least 3 months' duration;
- Mental competence;
- Willingness to participate in the study;
- Calcidiol levels within normal range.
Who cannot join
- Pregnancy;
- Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
- Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
- Chronic alcoholism and/or drug addiction;
- Participation in a study of an investigational drug during the past 90 days;
- Allergy to tetracycline.
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- Planning to move out of the area within 2 years of the study;
- On active transplant list;
- Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics).
- Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
There are two major goals of this project:
- Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
- Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
- Conditions
- Renal Osteodystrophy
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
Because each method (QCT or DXA) yields a dichotomous response (bone loss: yes or no), the proportion of patients with a bone loss will be compared between the 2 methods by using the McNemar statistic for correlated proportions.
Measured: 4 years
Secondary outcomes (1)
Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
A stepwise logistic model will be used to determine which combination of PTH and bone markers best predicts low bone turnover.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal OsteodystrophyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartmut Malluche, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hartmut Malluche, MD, University of Kentucky
- Investigators
- Hartmut H Malluche, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859612
- Sponsor's protocol ID
- 1R01DK080770-01A1
- Other IDs
- 1R01DK080770-01A1
- Status last verified
- May 2017
- First submitted
- 9 Mar 2009
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Osteodystrophy: A Fresh Approach
- ClinicalTrials.gov ID
- NCT00859612
- Acronym / sponsor ID
- 1R01DK080770-01A1
- Conditions
- Renal Osteodystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Hartmut Malluche, MDUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Mar 2009 (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.
There are two major goals of this project:
- Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
- Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from dialysis clinics
Key inclusion criteria (5 listed)
- Aged 18 years or older;
- Chronic maintenance dialysis of at least 3 months' duration;
- Mental competence;
- Willingness to participate in the study;
- Calcidiol levels within normal range.
Key exclusion criteria (10 listed)
- Pregnancy;
- Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
- Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
- Chronic alcoholism and/or drug addiction;
- Participation in a study of an investigational drug during the past 90 days;
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
Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
Time frame: 4 years
Because each method (QCT or DXA) yields a dichotomous response (bone loss: yes or no), the proportion of patients with a bone loss will be compared between the 2 methods by using the McNemar statistic for correlated proportions.
1 secondary outcome
Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Hartmut H Malluche, MD principal investigator
University of Kentucky
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 Renal Osteodystrophy, run by Hartmut Malluche, MD at 1 site in United States.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 5 May 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss. (time frame: 4 years). 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 5 May 2017.