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COX Inhibition & Musculoskeletal Responses to Exercise (MOXI)

Objective

We are looking at the effects of the pain reliever ibuprofen on changes in muscle and bone due to exercise in older adults.

Benefits

Eligible women and men will receive at no cost:

  • health screening tests
  • a personalized and supervised exercise program

Initial screening tests include a physical exam, bone density scan, treacmill exercise test, and blood tests. Women and men who qualify will begin planned exercise training for 9 months at our exercise facility. Participants will take ibuprofen or an inactive pill (placebo) on the days they exercise.

Monetary compensation provided.

IRB Protocol Number
06-0769

All Other Trials

  • Bones, Joints, and Muscles
  • Drugs (Pharmacology)
Contact
Marsha Steirn at 720-848-6461
Eligibility and Other Participant Information

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
  • PPI (Proton Pump Inhibitor) 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, testosterone, bisphosphonates, teriparatide, calcitonin, GnRH 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