OsteoarthritisNCT00104312
Osteoarthritis: Weakness From Inflammation
An observational study of Osteoarthritis, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to understand the factors that lead to muscle weakness with arthritis and aging. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to May 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community - Men and women
Who may be able to join
- 50 years of age or older
- Normal body weight (a Body Mass Index (BMI) of 30 or less)
- Osteoarthritis of the knee (prior to knee surgery)
- Planning to have knee surgery at a MedStar Hospital
Who cannot join
- History of a stroke
- History of muscle weakness or paralysis
- History of Rheumatoid Arthritis or
- Inflammatory Joint Disease
- History of a Bleeding Disorder
- History of Gout
- Diabetes for which you take insulin
- Polymyalgia rheumatica (total body muscle aching/stiffness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weakness From Inflammation: A Basis of Disability From Knee Osteoarthritis
The purpose of this study is to understand the factors that lead to muscle weakness with arthritis and aging.
Read the detailed description
Through this study, we hope to learn about the natural history of knee osteoarthritis and the disability that arises from it. We hope to better understand why people with knee osteoarthritis develop difficulty with mobility (e.g. walking, standing) in hopes of finding a cure.
This study requires 1 four-hour visit to Harbor Hospital. The visit involves a physical exam, a DEXA bone density scan, blood and urine testing, knee x-rays, strength testing and a surface electromyography (EMG). Samples of muscle, joint fluid and joint tissue will be collected during your planned surgery.
Participation in this study is entirely voluntary.
- Conditions
- Osteoarthritis
- Keywords
- Knee Osteoarthritis, Muscle, Cytokine, Mobility, Function
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
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 |
|---|---|---|
| 1 | Participants with symptomatic knee osteoarthritis | |
| 2 | Participants without symptomatic knee osteoarthritis, age-matched as controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2005 (estimated)
- Study startApr 2001
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Shari Ling, MD, Principal investigator, NIA, Johns Hopkins Medical Institution Divisions of Rheumatology, Gerontology, and Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104312
- Sponsor's protocol ID
- AG0016
- Status last verified
- May 2009
- First submitted
- 24 Feb 2005
- Last updated
- 29 May 2009
- Results posted
- No
Publications
Cooper C, Snow S, McAlindon TE, Kellingray S, Stuart B, Coggon D, Dieppe PA. Risk factors for the incidence and progression of radiographic knee osteoarthritis. Arthritis Rheum. 2000 May;43(5):995-1000. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-1.
PubMed 10817551Slemenda C, Heilman DK, Brandt KD, Katz BP, Mazzuca SA, Braunstein EM, Byrd D. Reduced quadriceps strength relative to body weight: a risk factor for knee osteoarthritis in women? Arthritis Rheum. 1998 Nov;41(11):1951-9. doi: 10.1002/1529-0131(199811)41:113.0.CO;2-9.
PubMed 9811049Conwit RA, Stashuk D, Tracy B, McHugh M, Brown WF, Metter EJ. The relationship of motor unit size, firing rate and force. Clin Neurophysiol. 1999 Jul;110(7):1270-5. doi: 10.1016/s1388-2457(99)00054-1.
PubMed 10423192
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weakness From Inflammation: A Basis of Disability From Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00104312
- Acronym / sponsor ID
- AG0016
- Conditions
- Osteoarthritis
- Keywords
- Knee Osteoarthritis, Muscle, Cytokine, Mobility, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Feb 2005 (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.
The purpose of this study is to understand the factors that lead to muscle weakness with arthritis and aging.
Detailed description
Through this study, we hope to learn about the natural history of knee osteoarthritis and the disability that arises from it. We hope to better understand why people with knee osteoarthritis develop difficulty with mobility (e.g. walking, standing) in hopes of finding a cure.
This study requires 1 four-hour visit to Harbor Hospital. The visit involves a physical exam, a DEXA bone density scan, blood and urine testing, knee x-rays, strength testing and a surface electromyography (EMG). Samples of muscle, joint fluid and joint tissue will be collected during your planned surgery.
Participation in this study is entirely voluntary.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants with symptomatic knee osteoarthritis |
| 2 | – | –Participants without symptomatic knee osteoarthritis, age-matched as controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community - Men and women
Key inclusion criteria (4 listed)
- 50 years of age or older
- Normal body weight (a Body Mass Index (BMI) of 30 or less)
- Osteoarthritis of the knee (prior to knee surgery)
- Planning to have knee surgery at a MedStar Hospital
Key exclusion criteria (8 listed)
- History of a stroke
- History of muscle weakness or paralysis
- History of Rheumatoid Arthritis or
- Inflammatory Joint Disease
- History of a Bleeding Disorder
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 29 May 2009.
- Background: PubMed 10817551Cooper C, Snow S, McAlindon TE, Kellingray S, Stuart B, Coggon D, Dieppe PA. Risk factors for the incidence and progression of radiographic knee osteoarthritis. Arthritis Rheum. 2000 May;43(5):995-1000. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-1.
- Background: PubMed 9811049Slemenda C, Heilman DK, Brandt KD, Katz BP, Mazzuca SA, Braunstein EM, Byrd D. Reduced quadriceps strength relative to body weight: a risk factor for knee osteoarthritis in women? Arthritis Rheum. 1998 Nov;41(11):1951-9. doi: 10.1002/1529-0131(199811)41:113.0.CO;2-9.
- Background: PubMed 10423192Conwit RA, Stashuk D, Tracy B, McHugh M, Brown WF, Metter EJ. The relationship of motor unit size, firing rate and force. Clin Neurophysiol. 1999 Jul;110(7):1270-5. doi: 10.1016/s1388-2457(99)00054-1.
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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.
Shari Ling, MD principal investigator
NIA, Johns Hopkins Medical Institution Divisions of Rheumatology, Gerontology, and Geriatrics
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 National Institute on Aging (NIA) 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 4 inclusion and 8 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 29 May 2009. 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?
On the ClinicalTrials.gov record for NCT00104312, which also lists 3 linked publications.
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 29 May 2009.