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Role of T-cells in Post-Menopausal Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00787904
First received: November 7, 2008
Last updated: October 21, 2016
Last verified: October 2016
Results First Received: June 22, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Osteoporosis

  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
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
  Description
Surgical Menopause Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
Surgical Control Pre-menopausal women with or without surgery

Participant Flow:   Overall Study
    Surgical Menopause   Surgical Control
STARTED   6   13 
COMPLETED   6   13 
NOT COMPLETED   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
Surgical Menopause Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
Surgical Control Pre-menopausal women undergoing abdominal surgery but without ovary removal
Total Total of all reporting groups

Baseline Measures
   Surgical Menopause   Surgical Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   13   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.3  (5.1)   41.4  (7.1)   42.9  (6.5) 
Gender 
[Units: Participants]
     
Female   6   13   19 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   8   10 
White   4   5   9 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures
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1.  Primary:   Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells   [ Time Frame: 2 years ]

2.  Primary:   Percent Change in Thymus Size Measured by CT Scan   [ Time Frame: 2 years ]

3.  Secondary:   Bone Mineral Density   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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:  
Name/Title: Vin Tangpricha
Organization: Emory University
phone: 404-727-7254
e-mail: vin.tangpricha@emory.edu



Responsible Party: Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00787904     History of Changes
Other Study ID Numbers: T-cells in osteoporosis
Study First Received: November 7, 2008
Results First Received: June 22, 2015
Last Updated: October 21, 2016