Osteoarthritis of the KneePhase 1NCT00833157
Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
A Phase 1 study testing glucosamine sulphate and ibuprofen in people with Osteoarthritis of the Knee, run by Bispebjerg Hospital.
Trial summary
The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis. The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- glucosamine sulphate and ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Mar 2009
- Phase
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 70 years
- Bilateral tibiofemoral osteoarthritis of the knee on x-ray
- American College of Rheumatology (ACR) clinical classification criteria
Who cannot join
- Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases
- Excess alcohol use (> 21 alcoholic drinks per week)
- Severe overweight (BMI > 35)
- History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion
About this study
The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.
The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- glucosamine sulphate, ibuprofen, placebo
- Keywords
- Knee Osteoarthritis, exercise, strength training, Glucosamine, Dietary supplement, Ibuprofen, NSAID
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucosamine sulphateDrug
Also called glucosamine from Ferrosan
Subjects are administered glucosamine-sulphate tablets of 500 mg * 3 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks.
ibuprofenDrug
Also called "Ibumetin" from Nycomed (vnr:38 83 71)
Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks
placeboDrug
Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine | Experimental | Not described Receives: Drug: glucosamine sulphate |
| Ibuprofen | Experimental | Not described Receives: Drug: ibuprofen |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength and hypertrophy
Measured: We measure before and after 12-weeks strength training.
cartilage biomarkers
Measured: We measure before and after 12 weeks strength training
Secondary outcomes (1)
muscle regeneration and function
Measured: We measure before and after 12-weeks strength training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startFeb 2005
- Primary completionJul 2007
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, The Danish Rheumatism Association, Ministry of the Interior and Health, Denmark
- Investigators
- Susanne G Petersen, MD, Principal investigator, Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833157
- Sponsor's protocol ID
- HIM-037
- Other IDs
- KF-01-18904
- Status last verified
- Jan 2009
- First submitted
- 29 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.
PubMed 21807137Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.
PubMed 19679221
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
- ClinicalTrials.gov ID
- NCT00833157
- Acronym / sponsor ID
- HIM-037
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Knee Osteoarthritis, exercise, strength training, Glucosamine, Dietary supplement, Ibuprofen, NSAID
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Lund University, The Danish Rheumatism Association, Ministry of the Interior and Health, Denmark
- Study start
- Feb 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Mar 2009 (estimated)
- First posted
- 30 Jan 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.
The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.
The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucosamine | Experimental | Drug: glucosamine sulphate |
| Ibuprofen | Experimental | Drug: ibuprofen |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 to 70 years
- Bilateral tibiofemoral osteoarthritis of the knee on x-ray
- American College of Rheumatology (ACR) clinical classification criteria
Key exclusion criteria (4 listed)
- Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases
- Excess alcohol use (> 21 alcoholic drinks per week)
- Severe overweight (BMI > 35)
- History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion
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 |
|---|---|---|
| glucosamine sulphateAlso: glucosamine from FerrosanSubjects are administered glucosamine-sulphate tablets of 500 mg * 3 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks. | Drug | Glucosamine |
| ibuprofenAlso: "Ibumetin" from Nycomed (vnr:38 83 71)Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks | Drug | Ibuprofen |
| placeboSubjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks | Drug | Placebo |
Primary outcome
muscle strength and hypertrophy
Time frame: We measure before and after 12-weeks strength training.
cartilage biomarkers
Time frame: We measure before and after 12 weeks strength training
1 secondary outcome
muscle regeneration and function
Time frame: We measure before and after 12-weeks strength training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 21807137Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.
- Derived from this study: PubMed 19679221Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.
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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.
Susanne G Petersen, MD principal investigator
Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glucosamine sulphate and ibuprofen in people with Osteoarthritis of the Knee, 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 3 inclusion and 4 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 30 Jan 2009. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
muscle strength and hypertrophy (time frame: We measure before and after 12-weeks strength training.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833157, which also lists 2 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 30 Jan 2009.