Myogenic and Osteogenic Responses to eXercise and Ibuprofen

NCT00462722 | Completed Results DMC

• 2 other identifiers: 06-0769R01AG018857
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Physical Fitness

Keywords

body composition; bone density; cyclooxygenase inhibitor; bone metabolism; muscle function; muscle strength

Outcome Measures

Primary Outcomes (3)

• Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months

  Baseline and after 9 months of training

• Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months

  Baseline and after 9 months of training

• Change From Baseline in Fat-free Mass at 9 Months

  Baseline and after 9 months of training

Secondary Outcomes (6)

• Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months

  Baseline and after 9 months of training

• Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months

  Baseline and after 9 months of training

• Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months

  Baseline and after 9 months of training

• Change in Thigh Cross-sectional Muscle Area

  Baseline and after 9 months of training

• Bone Turnover Markers

  Baseline, and after 4.5 & 9 months of training

Study Arms (3)

Placebo pre and post exercise

PLACEBO COMPARATOR

placebo before and after musculoskeletal-loading exercise

Drug: Placebo; Behavioral: musculoskeletal-loading exercise

Placebo pre and ibuprofen post exercise

EXPERIMENTAL

placebo before and ibuprofen after musculoskeletal-loading exercise

Drug: Ibuprofen; Drug: Placebo; Behavioral: musculoskeletal-loading exercise

Ibuprofen pre and placebo post exercise

EXPERIMENTAL

ibuprofen before and placebo after musculoskeletal-loading exercise

Drug: Ibuprofen; Drug: Placebo; Behavioral: musculoskeletal-loading exercise

Interventions

Ibuprofen DRUG

400 mg with each exercise session (up to 5 days per week) for 9 months

Also known as: Motrin, Advil

Ibuprofen pre and placebo post exercise; Placebo pre and ibuprofen post exercise

Placebo DRUG

with each exercise session (up to 5 days per week) for 9 months

Ibuprofen pre and placebo post exercise; Placebo pre and ibuprofen post exercise; Placebo pre and post exercise

musculoskeletal-loading exercise BEHAVIORAL

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

Ibuprofen pre and placebo post exercise; Placebo pre and ibuprofen post exercise; Placebo pre and post exercise

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Relative or absolute contraindications to regular use of NSAIDs
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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.

  PMID: 8074209 BACKGROUND

• Li 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.

  PMID: 12004337 BACKGROUND

• Trappe 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.

  PMID: 11832356 BACKGROUND

• Wherry 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.

  PMID: 33876259 DERIVED

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

The study did not include a no-exercise control group. The variability in the BMD responses was greater than expected. The results may be specific to ibuprofen and not to other NSAIDs.

Results Point of Contact

• Title: Catherine Jankowski
• Organization: University of Colorado Anschutz Medical Campus

catherine.jankowski@ucdenver.edu

303-724-7383

Study Officials

• Wendy Kohrt, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 2, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-10

Locations

US (1)