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

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ClinicalTrials.gov Identifier: NCT00412841
Recruitment Status : Terminated
First Posted : December 19, 2006
Results First Posted : March 3, 2016
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Avascular Necrosis
Interventions: Drug: Atorvastatin
Procedure: MRI, Venipuncture
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Atorvastatin 40 mg
Placebo No text entered.

Participant Flow:   Overall Study
    Atorvastatin   Placebo
STARTED   22   21 
COMPLETED   12   16 

  Baseline Characteristics

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.
No text entered.

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

Baseline Measures
   Atorvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   21   43 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      22 100.0%      21 100.0%      43 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Full Range)
 (18 to 58) 
 (20 to 57) 
 (18 to 58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      19  86.4%      17  81.0%      36  83.7% 
Male      3  13.6%      4  19.0%      7  16.3% 
Region of Enrollment 
[Units: Participants]
United States   22   21   43 

  Outcome Measures

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.  

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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

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


Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00412841     History of Changes
Other Study ID Numbers: H-8795
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: May 28, 2014
Results First Posted: March 3, 2016
Last Update Posted: December 8, 2017