Myogenic and Osteogenic Responses to eXercise and Ibuprofen

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute on Aging (NIA)
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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