Trial Outcomes & Findings for Myogenic and Osteogenic Responses to eXercise and Ibuprofen (NCT NCT00462722)
NCT ID: NCT00462722
Last Updated: 2015-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
Baseline and after 9 months of training
Results posted on
2015-11-02
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
55
|
54
|
|
Overall Study
COMPLETED
|
37
|
51
|
42
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myogenic and Osteogenic Responses to eXercise and Ibuprofen
Baseline characteristics by cohort
| Measure |
Placebo Pre and Post Exercise
n=37 Participants
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
n=51 Participants
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
n=42 Participants
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
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 4 • n=5 Participants
|
64 years
STANDARD_DEVIATION 4 • n=7 Participants
|
66 years
STANDARD_DEVIATION 4 • n=5 Participants
|
64 years
STANDARD_DEVIATION 4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
51 participants
n=7 Participants
|
42 participants
n=5 Participants
|
130 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: One participant in the "Ibuprofen pre and placebo post exercise" group had an uninterpretable spine scan.
Outcome measures
| Measure |
Placebo Pre and Post Exercise
n=37 Participants
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
n=50 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months
|
1.3 Percentage change in lumbar spine BMD
Standard Deviation 2.8
|
1.5 Percentage change in lumbar spine BMD
Standard Deviation 2.5
|
0.9 Percentage change in lumbar spine BMD
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: One participant in the "Placebo pre and post exercise" group and two participants in the "Ibuprofen pre and placebo post exercise" group had uninterpretable hip scans.
Outcome measures
| Measure |
Placebo Pre and Post Exercise
n=36 Participants
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
n=49 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months
|
0.5 percentage change in total hip BMD
Standard Deviation 2.6
|
0.0 percentage change in total hip BMD
Standard Deviation 1.9
|
-0.3 percentage change in total hip BMD
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Baseline and after 9 months of trainingOutcome measures
| Measure |
Placebo Pre and Post Exercise
n=37 Participants
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
n=51 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Change From Baseline in Fat-free Mass at 9 Months
|
0.6 change in kg
Standard Deviation 1.1
|
0.4 change in kg
Standard Deviation 1.6
|
0.6 change in kg
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: One participant in the "Placebo pre and post exercise" group and two participants in the "Ibuprofen pre and placebo post exercise" group had uninterpretable spine scans.
Outcome measures
| Measure |
Placebo Pre and Post Exercise
n=36 Participants
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
n=49 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months
|
0.2 percentage change in BMD
Standard Deviation 2.9
|
0.2 percentage change in BMD
Standard Deviation 2.8
|
-0.1 percentage change in BMD
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and after 9 months of trainingOutcome measures
| Measure |
Placebo Pre and Post Exercise
n=36 Participants
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
n=49 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months
|
1.1 percentage change in BMD
Standard Deviation 3.1
|
0.0 percentage change in BMD
Standard Deviation 2.3
|
-0.1 percentage change in BMD
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: One participant in the "Placebo pre and post exercise" group and two participants in the "Ibuprofen pre and placebo post exercise" groups had uninterpretable hip scans.
Outcome measures
| Measure |
Placebo Pre and Post Exercise
n=36 Participants
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
n=49 Participants
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
n=42 Participants
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
|
|---|---|---|---|
|
Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months
|
0.5 percentage change in BMD
Standard Deviation 3.4
|
0.0 percentage change in BMD
Standard Deviation 2.3
|
-0.3 percentage change in BMD
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: Because of the costs associated with data analysis for this secondary outcome, we did not pursue the analysis after learning the results of the primary outcome (fat-free mass).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, and after 4.5 & 9 months of trainingPopulation: Because of the costs associated with the assays and data analysis of bone turnover markers, we did not pursue data collection after learning of the primary outcomes (changes in BMD).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and after 9 months of trainingPopulation: Because of the costs associated with gene and protein expression techniques and data reduction, we did not pursue this secondary outcome after learning the results of the primary outcome (change in fat-free mass).
Outcome measures
Outcome data not reported
Adverse Events
Placebo Pre and Post Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen Pre and Placebo Post Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Pre and Ibuprofen Post Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Pre and Post Exercise
n=37 participants at risk
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
n=51 participants at risk
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
n=42 participants at risk
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
|
|---|---|---|---|
|
Renal and urinary disorders
change in estimated glomerular filtration rate (eGFR)
|
0.00%
0/37
|
2.0%
1/51 • Number of events 1
|
0.00%
0/42
|
Additional Information
Catherine Jankowski
University of Colorado Anschutz Medical Campus
Phone: 303-724-7383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place