OsteoarthritisNCT00505297
A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography
An observational study of Osteoarthritis, run by University of California, San Francisco at 1 site in United States.
Trial summary
In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept studies, this study is being conducted to assess magnetic resonance imaging (MRI) measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the progression of disease in subjects with potentially… Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2007
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients evaluated to be relatively in good health
- 40 years old and above
- Negative pregnancy test
- Additional inclusion criteria for OA patients:
- Frequent knee symptoms in the past year, defined as:
- pain, aching, or stiffness on most days of a month during the past year
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- use od medication (all types) for treatment of knee pain on most days of a month during the past year
- Kellgren \& Lawrence Grades 2 or 3 of the study knee (with either the same or less severe OA , or no OA in the contralateral knee)
- Body mass index (BMI) of 30 and above
- Medial joint space width of 2 mm and above
- Additional inclusion criteria for age-matched controls:
- BMI of 28 and above
- No evidence of knee OA in either knee (i.e., Kellgren \& Lawrence Grade 0 diagnosed by x-ray on AP view; infrequent knee pain, aching, stiffness during the past year; infrequent use of medication (all types) for treatment of knee pain during the past year.
Who cannot join
- Anticipated need for knee surgery in the next 2 years
- OA predominantly in the lateral tibiofemoral compartment measured by PA x-ray view of the study knee
- Intra-articular steroids to study joint (3 month washout), intra-articular hyaluronic acid to the study joint (3 month-washout), doxycycline (3 month washout), or arthroscopy within the last 6 months
- Medial joint space width less than 2 mm measured by PA view of knee x-ray
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty, or meniscectomy of the study knee
- History of other diseases that may involve the study joint including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic, diseases, knee infection of the study knee, neuropathic disorders, avascular necrosis, Paget's disease, or tumors (chondrocalcinosis is acceptable; treated thyroid disease is acceptable)
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- Systemic inflammatory diseases (e.g., Rheumatoid arthritis)
- Other pain that the principal investigator feels can not be distinguished from knee pain (e.g., lumbar pain, hip pain, trochanteric bursitis)
- Musculoskeletal pain that may preclude the subject from remaining motionless for the MRI acquisitions
- Unable to undergo an MRI exam of the knee because of contraindications
- Unable to receive gadopentate contrast agent injection because of contraindications. A study subject who displays any sign of an allergic reaction to the contrast agent will be withdrawn from the dGEMRIC part of the protocol and will not receive any subsequent contrast agent injection. The subject may continue to complete the remainder fo the study, which includes MR morphometry scan, collection of blood and urine sample for biomarker assays, and completion of study questionnaires.
- Clinical chemistry laboratory values more than 2 times the upper limit of normal
- Participation in clinical trial with a study during in the past 14 days
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry in the this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - San Frnacisco
San Francisco, California, 94107
About this study
In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept studies, this study is being conducted to assess magnetic resonance imaging (MRI) measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the progression of disease in subjects with potentially rapidly progressing OA. The subject population is selected to have higher likelihood of having rapidly progressing OA (i.e., a more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may be more likely to have changes in GAG content and/or cartilage volume. The results of this study may provide a reasonable means to assess DMOAD activity of drugs in development. The non-OA controls are included to determine the rate of change for subjects of similar age. Ideally, results of this study will identify reliable methods for delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC) and MRI cartilage assessment that correlate with OA disease progression as compared to x-ray changes.
Read the detailed description
The objective of the study are:
- Evaluate OA progression by evaluating cartilage morphology, cartilage glycosaminoglycan (GAG) content, and joint space changes measured by MRI (3.0T), dGEMRIC index, and radiography, respectively using age-matched control subjects to identify disease related changes.
- Identify subject characteristics associated with more rapidly progressing OA.
- Identify most sensitive efficacy endpoints for future DMOAD proof of concept (POC) studies.
- Establish time interval for future studies based on MRI endpoints.
- Evaluate the effect of contrast agent on MRI cartilage morphology and T2 measurements
- Define criteria for classifying cartilage legions/deficits using dGEMRIC and T2 measurements.
- Collect biofluid samples for future validation of disease specific biomarkers.
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis (OA), Magnetic Resonance Imaging (MRI), delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC), disease modifying osteoarthritis drug (DMOAD), Potentially rapidly progressing osteoarthritis, MRI measurement of cartilage
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| A | Subjects with potentiall rapidl progressing OA | |
| B | Age-matched healthy subjects with no knee pain |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startAug 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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-control
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Sharmila Majumdar, PhD, Principal investigator, University of California, San FranciscoThomas M. Link, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505297
- Sponsor's protocol ID
- A9001140
- Other IDs
- H6513-25393
- Status last verified
- Oct 2006
- First submitted
- 20 Jul 2007
- Last updated
- 23 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography
- ClinicalTrials.gov ID
- NCT00505297
- Acronym / sponsor ID
- A9001140
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis (OA), Magnetic Resonance Imaging (MRI), delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC), disease modifying osteoarthritis drug (DMOAD), Potentially rapidly progressing osteoarthritis, MRI measurement of cartilage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Jul 2007 (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.
In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept studies, this study is being conducted to assess magnetic resonance imaging (MRI) measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the progression of disease in subjects with potentially rapidly progressing OA. The subject population is selected to have higher likelihood of having rapidly progressing OA (i.e., a more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may be more likely to have changes in GAG content and/or cartilage volume. The results of this study may provide a reasonable means to assess DMOAD activity of drugs in development. The non-OA controls are included to determine the rate of change for subjects of similar age. Ideally, results of this study will identify reliable methods for delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC) and MRI cartilage assessment that correlate with OA disease progression as compared to x-ray changes.
Detailed description
The objective of the study are:
- Evaluate OA progression by evaluating cartilage morphology, cartilage glycosaminoglycan (GAG) content, and joint space changes measured by MRI (3.0T), dGEMRIC index, and radiography, respectively using age-matched control subjects to identify disease related changes.
- Identify subject characteristics associated with more rapidly progressing OA.
- Identify most sensitive efficacy endpoints for future DMOAD proof of concept (POC) studies.
- Establish time interval for future studies based on MRI endpoints.
- Evaluate the effect of contrast agent on MRI cartilage morphology and T2 measurements
- Define criteria for classifying cartilage legions/deficits using dGEMRIC and T2 measurements.
- Collect biofluid samples for future validation of disease specific biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subjects with potentiall rapidl progressing OA |
| B | – | –Age-matched healthy subjects with no knee pain |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female patients evaluated to be relatively in good health
- 40 years old and above
- Negative pregnancy test
- Frequent knee symptoms in the past year, defined as:
- pain, aching, or stiffness on most days of a month during the past year
Key exclusion criteria (14 listed)
- Anticipated need for knee surgery in the next 2 years
- OA predominantly in the lateral tibiofemoral compartment measured by PA x-ray view of the study knee
- Intra-articular steroids to study joint (3 month washout), intra-articular hyaluronic acid to the study joint (3 month-washout), doxycycline (3 month washout), or arthroscopy within the last 6 months
- Medial joint space width less than 2 mm measured by PA view of knee x-ray
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty, or meniscectomy of the study knee
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
Not reported in the source record.
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 23 Jul 2007.
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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.
Sharmila Majumdar, PhD principal investigator
University of California, San Francisco
Thomas M. Link, M.D. principal investigator
University of California, San Francisco
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 Osteoarthritis, run by University of California, San Francisco 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 13 inclusion and 14 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 23 Jul 2007. 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.
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 23 Jul 2007.