OsteoarthritisEarly Phase 1NCT01090375
Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
A Early Phase 1 study testing Exercise and Non Exercise in people with Osteoarthritis and Exercise, run by Bispebjerg Hospital.
Trial summary
In the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Osteoarthritis, Exercise
- What is being tested?
- Exercise and Non Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2008to Mar 2009
- Phase
- Early Phase 1
- 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 55 to 75 years
- Women only
- Adult, Older adult
Who may be able to join
- verified osteoarthritis (x-ray)of the knee, female,
Who cannot join
- dementia, inflammatory diseases, regular pain medication
About this study
In the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. The aim of the present study was, by applying the microdialysis technique, to monitor markers of cartilage breakdown and inflammation in 2 different positions of the knee (inside and in the inner part of the knee capsule) in a group of human females with knee osteoarthritis over a period of 3 hours.
- Conditions
- Osteoarthritis, Exercise
- Being tested
- Exercise, Non Exercise
- Keywords
- osteoarthritis, biochemical markers, cartilage, inflammation, microdialysis
- Medical subject headings
- Osteoarthritis, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Non ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Other: Exercise |
| Non Exercise | Placebo comparator | Not described Receives: Other: Non Exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association, Danish Ministry of Health, Internal Affairs, Danish National Research Council, The Danish Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090375
- Sponsor's protocol ID
- H-KF-306126
- Status last verified
- Mar 2010
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Helmark IC, Mikkelsen UR, Borglum J, Rothe A, Petersen MC, Andersen O, Langberg H, Kjaer M. Exercise increases interleukin-10 levels both intraarticularly and peri-synovially in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Res Ther. 2010;12(4):R126. doi: 10.1186/ar3064. Epub 2010 Jul 1.
PubMed 20594330
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
- ClinicalTrials.gov ID
- NCT01090375
- Acronym / sponsor ID
- H-KF-306126
- Conditions
- Osteoarthritis, Exercise
- Keywords
- osteoarthritis, biochemical markers, cartilage, inflammation, microdialysis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association, Danish Ministry of Health, Internal Affairs, Danish National Research Council, The Danish Medical Research Council
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- First posted
- 19 Mar 2010 (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 the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. The aim of the present study was, by applying the microdialysis technique, to monitor markers of cartilage breakdown and inflammation in 2 different positions of the knee (inside and in the inner part of the knee capsule) in a group of human females with knee osteoarthritis over a period of 3 hours.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise |
| Non Exercise | Placebo comparator | Other: Non Exercise |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- verified osteoarthritis (x-ray)of the knee, female,
Key exclusion criteria (1 listed)
- dementia, inflammatory diseases, regular pain medication
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 |
|---|---|---|
| Exercise | Other | Exercise |
| Non Exercise | Other | Non Exercise |
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 19 Mar 2010.
- Derived from this study: PubMed 20594330Helmark IC, Mikkelsen UR, Borglum J, Rothe A, Petersen MC, Andersen O, Langberg H, Kjaer M. Exercise increases interleukin-10 levels both intraarticularly and peri-synovially in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Res Ther. 2010;12(4):R126. doi: 10.1186/ar3064. Epub 2010 Jul 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exercise and Non Exercise in people with Osteoarthritis and Exercise, run by Bispebjerg Hospital.
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 1 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: finished, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT01090375, which also lists 1 linked publication.
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 19 Mar 2010.