AgingMOXINCT00462722
Myogenic and Osteogenic Responses to eXercise and Ibuprofen
A study testing Ibuprofen and musculoskeletal-loading exercise in people with Aging and Physical Fitness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of ibuprofen blocks the benefits of exercise to build bone and muscle mass. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Fitness
- What is being tested?
- Ibuprofen and musculoskeletal-loading exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 to 75 years
- Willing to participate in a 9-month supervised exercise program that will start at a moderate intensity and gradually progress to a vigorous intensity
- Not currently performing regular, moderate-to-vigorous weight-bearing or weight-lifting exercise
- Average use of NSAIDs (including low-dose aspirin) or acetaminophen less than 3 days per month
Who cannot join
- Relative or absolute contraindications to regular use of NSAIDs
- Known allergy or intolerance (heartburn, stomach pain, nausea, vomiting) to NSAIDs; controlled GERD(Gastroesophageal Reflux Disease), if not related to NSAID use, will not be an exclusion criterion
- Proton Pump Inhibitor (PPI) use if dose is unstable or if using for less than 6 months prior to study enrollment
- History of peptic ulcer or upper GI bleeding
- Anemia
- Asthma with bronchospasm induced by aspirin or other NSAIDs
Show all 22Show fewer
- Moderate or severe renal impairment defined as a calculated creatinine clearance
- Chronic hepatobiliary disease, conservatively defined as liver function tests greater than 1.5 times the upper limit of normal (if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed)
- Hyperkalemia
- Osteoporosis
- Diabetes mellitus requiring pharmacologic therapy
- Congestive heart failure
- Uncontrolled hypertension; use of thiazide diuretics will be allowed if on a stable dose for at least 6 months
- Cardiovascular disease
- Thyroid dysfunction
- Orthopedic problems (e.g., chronic back pain, severe osteoarthritis, rheumatoid arthritis) that limit the ability to perform vigorous exercise and increase the likelihood that the volunteer will use pain medications other than the study pills
- Certain use of medications, including
- Drugs that are known to alter bone metabolism (e.g., estrogen, SERMs(Selective estrogen-receptor modulators), testosterone, bisphosphonates, teriparatide, calcitonin, GnRH(Gonadotropin-releasing hormone) agonists)
- Chronic use of oral corticosteroids or any use in the previous 6 months (use of inhaled steroids will not be an exclusion criterion based on a meta-analysis documenting that the effect on bone is not significant)
- Average use of acetaminophen or NSAIDs, including low-dose aspirin, greater than 3 days per month; volunteers using aspirin for primary prevention may enroll in the study if they discontinue aspirin therapy for the 9-month intervention period
- Anticoagulants (e.g., warfarin, clopidogrel)
- Narcotics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: COX Inhibition & Musculoskeletal Responses to Exercise
The purpose of this study is to determine if the use of ibuprofen blocks the benefits of exercise to build bone and muscle mass.
Read the detailed description
People are advised to engage in weight-bearing physical activity to help prevent the loss of bone and muscle mass that occurs with aging. There is evidence from studies of animals that non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, block some of the bone- and muscle-building effects of exercise. The aim of this study is to determine whether use of ibuprofen, either before or after exercise, blocks the benefits of exercise training on bone and skeletal muscle in older women and men. The hypothesis is that taking ibuprofen before exercise will block some of the effects of exercise training to increase bone density and muscle mass.
Women and men aged 60-75 years will complete a supervised, 9-month exercise training program designed to increase bone and muscle mass. The training will include weight lifting and weight-bearing exercises, such as jumping in place and treadmill walking, up to 5 days per week. Participants will be randomly assigned to take 1 of 3 study pill combinations before and after each exercise session. The combinations of study pills will be: placebo before/placebo after, placebo before/ibuprofen after, or ibuprofen before/placebo after. The dose of ibuprofen will be 400 mg. Bone density of the hip and spine, body composition (total body muscle and fat), and markers of bone turnover in the blood will be measured before and after 4.5 and 9 months of training. Muscle cross-sectional area of the thigh will be measured by CT before and after 9 months of training. A subset of participants will have biopsies of the thigh muscle before and after training to measure proteins and genes associated with muscle build-up and breakdown.
Volunteers who do not use ibuprofen, aspirin, or acetaminophen more than 3 days per month will be enrolled. People with intolerance to ibuprofen or related drugs, cardiovascular disease, or orthopedic problems that limit exercise will be excluded from the study.
- Conditions
- Aging, Physical Fitness
- Being tested
- Ibuprofen, Placebo, musculoskeletal-loading exercise
- Keywords
- body composition, bone density, cyclooxygenase inhibitor, bone metabolism, muscle function, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin, Advil
400 mg with each exercise session (up to 5 days per week) for 9 months
PlaceboDrug
with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exerciseBehavioural
Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo pre and post exercise | Placebo comparator | placebo before and after musculoskeletal-loading exercise Receives: Drug: Placebo; Behavioral: musculoskeletal-loading exercise |
| Placebo pre and ibuprofen post exercise | Experimental | placebo before and ibuprofen after musculoskeletal-loading exercise Receives: Drug: Ibuprofen; Drug: Placebo; Behavioral: musculoskeletal-loading exercise |
| Ibuprofen pre and placebo post exercise | Experimental | ibuprofen before and placebo after musculoskeletal-loading exercise Receives: Drug: Ibuprofen; Drug: Placebo; Behavioral: musculoskeletal-loading exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months
Measured: Baseline and after 9 months of training
Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months
Measured: Baseline and after 9 months of training
Change From Baseline in Fat-free Mass at 9 Months
Measured: Baseline and after 9 months of training
Secondary outcomes (6)
Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months
Measured: Baseline and after 9 months of training
Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months
Measured: Baseline and after 9 months of training
Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months
Measured: Baseline and after 9 months of training
Change in Thigh Cross-sectional Muscle Area
Measured: Baseline and after 9 months of training
Bone Turnover Markers
Measured: Baseline, and after 4.5 & 9 months of training
Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown
Measured: Baseline and after 9 months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Wendy Kohrt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462722
- Sponsor's protocol ID
- 06-0769
- Other IDs
- R01AG018857
- Acronym
- MOXI
- Status last verified
- Oct 2015
- First submitted
- 17 Apr 2007
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chow JW, Chambers TJ. Indomethacin has distinct early and late actions on bone formation induced by mechanical stimulation. Am J Physiol. 1994 Aug;267(2 Pt 1):E287-92. doi: 10.1152/ajpendo.1994.267.2.E287.
PubMed 8074209Li J, Burr DB, Turner CH. Suppression of prostaglandin synthesis with NS-398 has different effects on endocortical and periosteal bone formation induced by mechanical loading. Calcif Tissue Int. 2002 Apr;70(4):320-9. doi: 10.1007/s00223-001-1025-y. Epub 2002 Mar 26.
PubMed 12004337Trappe TA, White F, Lambert CP, Cesar D, Hellerstein M, Evans WJ. Effect of ibuprofen and acetaminophen on postexercise muscle protein synthesis. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E551-6. doi: 10.1152/ajpendo.00352.2001.
PubMed 11832356Wherry SJ, Wolfe P, Schwartz RS, Kohrt WM, Jankowski CM. Ibuprofen taken before exercise blunts the IL-6 response in older adults but does not alter bone alkaline phosphatase or c-telopeptide. Eur J Appl Physiol. 2021 Aug;121(8):2187-2192. doi: 10.1007/s00421-021-04691-8. Epub 2021 Apr 19.
PubMed 33876259
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COX Inhibition & Musculoskeletal Responses to Exercise
- ClinicalTrials.gov ID
- NCT00462722
- Acronym / sponsor ID
- MOXI / 06-0769
- Conditions
- Aging, Physical Fitness
- Keywords
- body composition, bone density, cyclooxygenase inhibitor, bone metabolism, muscle function, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 10 Aug 2015
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 determine if the use of ibuprofen blocks the benefits of exercise to build bone and muscle mass.
Detailed description
People are advised to engage in weight-bearing physical activity to help prevent the loss of bone and muscle mass that occurs with aging. There is evidence from studies of animals that non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, block some of the bone- and muscle-building effects of exercise. The aim of this study is to determine whether use of ibuprofen, either before or after exercise, blocks the benefits of exercise training on bone and skeletal muscle in older women and men. The hypothesis is that taking ibuprofen before exercise will block some of the effects of exercise training to increase bone density and muscle mass.
Women and men aged 60-75 years will complete a supervised, 9-month exercise training program designed to increase bone and muscle mass. The training will include weight lifting and weight-bearing exercises, such as jumping in place and treadmill walking, up to 5 days per week. Participants will be randomly assigned to take 1 of 3 study pill combinations before and after each exercise session. The combinations of study pills will be: placebo before/placebo after, placebo before/ibuprofen after, or ibuprofen before/placebo after. The dose of ibuprofen will be 400 mg. Bone density of the hip and spine, body composition (total body muscle and fat), and markers of bone turnover in the blood will be measured before and after 4.5 and 9 months of training. Muscle cross-sectional area of the thigh will be measured by CT before and after 9 months of training. A subset of participants will have biopsies of the thigh muscle before and after training to measure proteins and genes associated with muscle build-up and breakdown.
Volunteers who do not use ibuprofen, aspirin, or acetaminophen more than 3 days per month will be enrolled. People with intolerance to ibuprofen or related drugs, cardiovascular disease, or orthopedic problems that limit exercise will be excluded from the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo pre and post exercise | Placebo comparator | Drug: Placebo, Behavioral: musculoskeletal-loading exerciseplacebo before and after musculoskeletal-loading exercise |
| Placebo pre and ibuprofen post exercise | Experimental | Drug: Ibuprofen, Drug: Placebo, Behavioral: musculoskeletal-loading exerciseplacebo before and ibuprofen after musculoskeletal-loading exercise |
| Ibuprofen pre and placebo post exercise | Experimental | Drug: Ibuprofen, Drug: Placebo, Behavioral: musculoskeletal-loading exerciseibuprofen before and placebo after musculoskeletal-loading exercise |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 to 75 years
- Willing to participate in a 9-month supervised exercise program that will start at a moderate intensity and gradually progress to a vigorous intensity
- Not currently performing regular, moderate-to-vigorous weight-bearing or weight-lifting exercise
- Average use of NSAIDs (including low-dose aspirin) or acetaminophen less than 3 days per month
Key exclusion criteria (22 listed)
- Relative or absolute contraindications to regular use of NSAIDs
- Known allergy or intolerance (heartburn, stomach pain, nausea, vomiting) to NSAIDs; controlled GERD(Gastroesophageal Reflux Disease), if not related to NSAID use, will not be an exclusion criterion
- Proton Pump Inhibitor (PPI) use if dose is unstable or if using for less than 6 months prior to study enrollment
- History of peptic ulcer or upper GI bleeding
- Anemia
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 |
|---|---|---|
| IbuprofenAlso: Motrin, Advil400 mg with each exercise session (up to 5 days per week) for 9 months | Drug | Ibuprofen pre and placebo post exercise, Placebo pre and ibuprofen post exercise |
| Placebowith each exercise session (up to 5 days per week) for 9 months | Drug | Ibuprofen pre and placebo post exercise, Placebo pre and ibuprofen post exercise, Placebo pre and post exercise |
| musculoskeletal-loading exerciseExercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months | Behavioural | Ibuprofen pre and placebo post exercise, Placebo pre and ibuprofen post exercise, Placebo pre and post exercise |
Primary outcome
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months
Time frame: Baseline and after 9 months of training
Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months
Time frame: Baseline and after 9 months of training
Change From Baseline in Fat-free Mass at 9 Months
Time frame: Baseline and after 9 months of training
6 secondary outcomes
Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months
Time frame: Baseline and after 9 months of training
Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months
Time frame: Baseline and after 9 months of training
Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months
Time frame: Baseline and after 9 months of training
Change in Thigh Cross-sectional Muscle Area
Time frame: Baseline and after 9 months of training
Bone Turnover Markers
Time frame: Baseline, and after 4.5 & 9 months of training
Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown
Time frame: Baseline and after 9 months of training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8074209Chow JW, Chambers TJ. Indomethacin has distinct early and late actions on bone formation induced by mechanical stimulation. Am J Physiol. 1994 Aug;267(2 Pt 1):E287-92. doi: 10.1152/ajpendo.1994.267.2.E287.
- Background: PubMed 12004337Li J, Burr DB, Turner CH. Suppression of prostaglandin synthesis with NS-398 has different effects on endocortical and periosteal bone formation induced by mechanical loading. Calcif Tissue Int. 2002 Apr;70(4):320-9. doi: 10.1007/s00223-001-1025-y. Epub 2002 Mar 26.
- Background: PubMed 11832356Trappe TA, White F, Lambert CP, Cesar D, Hellerstein M, Evans WJ. Effect of ibuprofen and acetaminophen on postexercise muscle protein synthesis. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E551-6. doi: 10.1152/ajpendo.00352.2001.
- Derived from this study: PubMed 33876259Wherry SJ, Wolfe P, Schwartz RS, Kohrt WM, Jankowski CM. Ibuprofen taken before exercise blunts the IL-6 response in older adults but does not alter bone alkaline phosphatase or c-telopeptide. Eur J Appl Physiol. 2021 Aug;121(8):2187-2192. doi: 10.1007/s00421-021-04691-8. Epub 2021 Apr 19.
- Data analysis plan MOXI StudyLink provided by the sponsor.
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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.
Wendy Kohrt, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and musculoskeletal-loading exercise in people with Aging and Physical Fitness, run by University of Colorado, Denver 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 22 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 2 Nov 2015. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months (time frame: Baseline and after 9 months of training). The study lists 3 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 NCT00462722, which also lists 4 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 2 Nov 2015.