NCT01083901

Brief Summary

The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET) interferes with some of the benefits of weight lifting on muscles and bone density in older men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 8, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

4.8 years

First QC Date

March 8, 2010

Results QC Date

February 4, 2013

Last Update Submit

June 17, 2013

Conditions

SarcopeniaOsteoporosisAging

Outcome Measures

Primary Outcomes (1)

  • Change in Total Body Fat-free Mass

    change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)

    16 weeks

Secondary Outcomes (3)

  • Change in Total Body Fat Mass

    16 weeks

  • Changes in Upper Body Strength.

    16 weeks

  • Change in Lower Body Strength

    16 weeks

Study Arms (3)

Resistance training with Acetaminophen

EXPERIMENTAL

Acetaminophen

Behavioral: Resistance training

Resistance Training with ibuprofen

EXPERIMENTAL

Ibuprofen

Behavioral: Resistance training

placebo

PLACEBO COMPARATOR

Placebo

Behavioral: Resistance training

Interventions

Resistance trainingBEHAVIORAL

high intensity progressive resistance exercise training

Resistance Training with ibuprofenResistance training with Acetaminophenplacebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • average use of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) \[including aspirin\] less than 3 days per month
  • not currently engaged in moderate-to-vigorous weight-lifting exercise
  • non-smoker
  • willing to participate in a supervised exercise program for 9 months

You may not qualify if:

  • relative or absolute contraindications to regular use of acetaminophen or NSAIDs including known allergy or intolerance to either drug,history of peptic ulcer or GI bleeding, anemia, asthma with bronchospasm induced by aspirin or other NSAIDS, moderate or severe renal impairment, known hepatobiliary disease
  • contraindications to exercise testing and training including congestive heart failure class III or IV, uncontrolled hypertension and unstable cardiovascular disease
  • thyroid dysfunction
  • orthopedic problems that limit the ability to perform vigorous exercise or increase the likelihood of the use of pain medications
  • drugs known to alter bone metabolism
  • allergy to lidocaine
  • diabetes mellitus requiring pharmacologic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

SarcopeniaOsteoporosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This was a preliminary study that was limited by small sample size, exclusion of women, and the duration of intervention which was too brief to measure changes in bone mineral density.

Results Point of Contact

Title
Catherine M. Jankowski
Organization
University of Colorado Denver
catherine.jankowski@ucdenver.edu
303-724-7383

Study Officials

  • Catherine Jankowski, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
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

March 8, 2010

First Posted

March 10, 2010

Study Start

May 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 24, 2013

Results First Posted

March 8, 2013

Record last verified: 2013-06

Locations

US(1)