Myogenic and Osteogenic Responses to eXercise and Ibuprofen (MOXI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00462722
First received: April 17, 2007
Last updated: July 10, 2015
Last verified: July 2015
Results First Received: June 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Conditions: Aging
Physical Fitness
Interventions: Drug: Ibuprofen
Drug: Placebo
Behavioral: musculoskeletal-loading exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Pre and Post Exercise

placebo before and after musculoskeletal-loading exercise

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

musculoskeletal-loading exercise: 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

ibuprofen before and placebo after musculoskeletal-loading exercise

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

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

musculoskeletal-loading exercise: 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

Placebo Pre and Ibuprofen Post Exercise

placebo before and ibuprofen after musculoskeletal-loading exercise

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

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

musculoskeletal-loading exercise: 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


Participant Flow:   Overall Study
    Placebo Pre and Post Exercise     Ibuprofen Pre and Placebo Post Exercise     Placebo Pre and Ibuprofen Post Exercise  
STARTED     50     55     54  
COMPLETED     37     51     42  
NOT COMPLETED     13     4     12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Pre and Post Exercise

placebo before and after musculoskeletal-loading exercise

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

musculoskeletal-loading exercise: 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

ibuprofen before and placebo after musculoskeletal-loading exercise

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

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

musculoskeletal-loading exercise: 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

Placebo Pre and Ibuprofen Post Exercise

placebo before and ibuprofen after musculoskeletal-loading exercise

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

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

musculoskeletal-loading exercise: 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

Total Total of all reporting groups

Baseline Measures
    Placebo Pre and Post Exercise     Ibuprofen Pre and Placebo Post Exercise     Placebo Pre and Ibuprofen Post Exercise     Total  
Number of Participants  
[units: participants]
  37     51     42     130  
Age  
[units: years]
Mean (Standard Deviation)
  64  (4)     64  (4)     66  (4)     64  (4)  
Gender  
[units: participants]
       
Female     23     32     27     82  
Male     14     19     15     48  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     2     1     5  
Not Hispanic or Latino     35     49     41     125  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     1     1     2  
Asian     1     1     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     2     5     7  
White     33     47     35     115  
More than one race     3     0     0     3  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     37     51     42     130  



  Outcome Measures
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1.  Primary:   Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

2.  Primary:   Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

3.  Primary:   Change From Baseline in Fat-free Mass at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

4.  Secondary:   Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

5.  Secondary:   Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

6.  Secondary:   Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months   [ Time Frame: Baseline and after 9 months of training ]

7.  Secondary:   Change in Thigh Cross-sectional Muscle Area   [ Time Frame: Baseline and after 9 months of training ]

8.  Secondary:   Bone Turnover Markers   [ Time Frame: Baseline, and after 4.5 & 9 months of training ]

9.  Secondary:   Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown   [ Time Frame: Baseline and after 9 months of training ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Catherine Jankowski
Organization: University of Colorado Anschutz Medical Campus
phone: 303-724-7383
e-mail: catherine.jankowski@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00462722     History of Changes
Other Study ID Numbers: 06-0769, R01AG018857
Study First Received: April 17, 2007
Results First Received: June 11, 2015
Last Updated: July 10, 2015
Health Authority: United States: Federal Government