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Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393848
Recruitment Status : Completed
First Posted : October 29, 2006
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Hip Fracture
Osteoarthritis
Femur Head Necrosis
Interventions Drug: Essential amino acid supplement
Drug: Ketoconazole
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Hide Arm/Group Description Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge. Usual clinical care with no dietary intervention. 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization. Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
Period Title: Overall Study
Started 16 9 6 9
Completed 16 9 4 8
Not Completed 0 0 2 1
Reason Not Completed
Surgical schedule             0             0             0             1
Personal reasons             0             0             2             0
Arm/Group Title Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo Total
Hide Arm/Group Description Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge. Usual clinical care - no dietary intervention. 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization. Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization. Total of all reporting groups
Overall Number of Baseline Participants 16 9 4 8 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 4 participants 8 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  81.3%
7
  77.8%
4
 100.0%
7
  87.5%
31
  83.8%
>=65 years
3
  18.8%
2
  22.2%
0
   0.0%
1
  12.5%
6
  16.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 9 participants 4 participants 8 participants 37 participants
55  (7) 56  (8) 44  (15) 46  (15) 51  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 4 participants 8 participants 37 participants
Female
7
  43.8%
3
  33.3%
2
  50.0%
2
  25.0%
14
  37.8%
Male
9
  56.3%
6
  66.7%
2
  50.0%
6
  75.0%
23
  62.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 9 participants 4 participants 8 participants 37 participants
16 9 4 8 37
1.Primary Outcome
Title Muscle Protein Synthesis
Hide Description [Not Specified]
Time Frame Perioperative and discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Hide Arm/Group Description:
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
Usual clinical care without dietary intervention
200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
Overall Number of Participants Analyzed 16 9 4 8
Mean (Standard Error)
Unit of Measure: %/d
Perioperative MPS 1.38  (0.12) 0.84  (0.11) 1.42  (0.48) 1.36  (0.22)
Discharge MPS 1.23  (0.16) 1.49  (0.18) NA [1]   (NA) NA [1]   (NA)
[1]
Not performed
2.Secondary Outcome
Title Change in Maximal Voluntary Contraction
Hide Description [Not Specified]
Time Frame Baseline and 6 weeks post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Measure not performed in Experiment 2
Arm/Group Title Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care
Hide Arm/Group Description:
Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
Usual clinical care with no dietary intervention.
Overall Number of Participants Analyzed 16 9
Mean (Standard Error)
Unit of Measure: kg/kg leg lean mass
0.68  (0.3) 0.34  (0.32)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Hide Arm/Group Description Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge. Usual clinical care with no dietary intervention. 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization. Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
All-Cause Mortality
Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/9 (11.11%)      0/6 (0.00%)      0/9 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Mastectomy for breast cancer  0/16 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experiment 1 - Amino Acid Supplement Experiment 1 - Standard of Care Experiment 2 - Ketoconazole Experiment 2 - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/9 (0.00%)      0/6 (0.00%)      0/9 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Arny Ferrando
Organization: UAMS
Phone: 501-526-5711
EMail: aferrando@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00393848    
Other Study ID Numbers: R01AR052293 ( U.S. NIH Grant/Contract )
70451
1R01AR052293-01A2 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2006
First Posted: October 29, 2006
Results First Submitted: January 6, 2014
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014