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Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Herbert Lindsley, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00682357
First received: May 20, 2008
Last updated: October 5, 2016
Last verified: October 2016
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Osteoarthritis
Interventions: Drug: Methylprednisolone and Lidocaine
Drug: Placebo and Lidocaine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1 - Standard Dose Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Group 2 - Low Dose Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
Group 3 - Placebo Placebo and Lidocaine: Placebo and lidocaine 20 mg

Participant Flow:   Overall Study
    Group 1 - Standard Dose   Group 2 - Low Dose   Group 3 - Placebo
STARTED   10   10   5 
COMPLETED   10   10   5 
NOT COMPLETED   0   0   0 



  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.
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Reporting Groups
  Description
Group 1 - Standard Dose Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Group 2 - Low Dose Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
Group 3 - Placebo Placebo and Lidocaine: Placebo and lidocaine 20 mg
Total Total of all reporting groups

Baseline Measures
   Group 1 - Standard Dose   Group 2 - Low Dose   Group 3 - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   5   25 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   7   8   4   19 
>=65 years   3   2   1   6 
Gender 
[Units: Participants]
       
Female   7   9   4   20 
Male   3   1   1   5 
Region of Enrollment 
[Units: Participants]
       
United States   10   10   5   25 


  Outcome Measures
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1.  Primary:   Change in Serum Osteocalcin   [ Time Frame: Change from Baseline Visit to Day 28 ]

2.  Primary:   Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)   [ Time Frame: Change from Baseline Visit to Day 28 ]

3.  Secondary:   Change in Testosterone   [ Time Frame: Change from Baseline Visit to Day 28 ]

4.  Secondary:   Change in Serum Cortisol   [ Time Frame: Change from Baseline Visit to Day 28 ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Herbert Lindsley
Organization: University of Kansas Medical Center
phone: (913) 588-3402
e-mail: HLINDSLE@kumc.edu



Responsible Party: Herbert Lindsley, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00682357     History of Changes
Other Study ID Numbers: 11199
Study First Received: May 20, 2008
Results First Received: October 5, 2016
Last Updated: October 5, 2016
Health Authority: United States: Institutional Review Board