Role of T-cells in Post-Menopausal Osteoporosis
The Role of T-cells in Women Undergoing Surgical Menopause
1 other identifier
observational
19
1 country
1
Brief Summary
This is an observational study of women undergoing surgical menopause to determine whether T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will examined before and after surgery and followed over a two year period to determine the biology of T-cells during this study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
December 13, 2016
CompletedDecember 13, 2016
October 1, 2016
4.5 years
November 7, 2008
June 22, 2015
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells
(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)
2 years
Percent Change in Thymus Size Measured by CT Scan
2 years
Secondary Outcomes (1)
Bone Mineral Density
2 years
Study Arms (3)
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
Healthy
Healthy matched pre-menopausal controls
Eligibility Criteria
Pre-menopausal Women
You may qualify if:
- Women between the age of 18-55, pre-menopausal by history (regular spontaneous menstrual bleeding every 21-35 days) or documented FSH \<10, no current estrogen therapy, undergoing hysterectomy with (ovx) or without ovariectomy (control group) for benign gynecologic disease (fibroid uterus, endometriosis, dysfunctional uterine bleeding, chronic pelvic pain) or for prophylaxis against ovarian cancer (BRCA positive).
You may not qualify if:
- History of an active cancer including breast and uterine cancer, treatment with chemotherapy or glucocorticoids
- History of an immune deficiency syndrome including HIV infection
- History of severe anemia with hematocrit \< 25.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlanta VA Medical Centerlead
- Emory Universitycollaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vin Tangpricha
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Vin Tangpricha, M.D./Ph.D.
Emory University/Atlanta VAMC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
December 1, 2006
Primary Completion
June 1, 2011
Study Completion
December 1, 2012
Last Updated
December 13, 2016
Results First Posted
December 13, 2016
Record last verified: 2016-10