Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00412841
First received: December 18, 2006
Last updated: February 3, 2016
Last verified: February 2016
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Avascular Necrosis
Interventions: Drug: Atorvastatin
Procedure: MRI, Venipuncture
Drug: Placebo

  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
Atorvastatin 40 mg
Placebo No text entered.

Participant Flow:   Overall Study
    Atorvastatin     Placebo  
STARTED     22     21  
COMPLETED     12     16  
NOT COMPLETED     10     5  



  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
Atorvastatin Atorvastatin 40mg
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Atorvastatin     Placebo     Total  
Number of Participants  
[units: participants]
  22     21     43  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     21     43  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Full Range)
  35  
  (18 to 58)  
  35  
  (20 to 57)  
  35  
  (18 to 58)  
Gender  
[units: participants]
     
Female     19     17     36  
Male     3     4     7  
Region of Enrollment  
[units: participants]
     
United States     22     21     43  



  Outcome Measures
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1.  Primary:   Number of Participants With AVN After 9 Months   [ Time Frame: 9 months ]

2.  Secondary:   Number of Participants With AVN After 4 Months   [ Time Frame: 4 months ]

3.  Secondary:   To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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. H. Michael Belmont
Organization: NYULMC
phone: 212-598-6518
e-mail: michael.belmont@nyumc.org


Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00412841     History of Changes
Other Study ID Numbers: H-8795
Study First Received: December 18, 2006
Results First Received: May 28, 2014
Last Updated: February 3, 2016
Health Authority: United States: Institutional Review Board