N/A
N=19
Role of T-cells in Post-Menopausal Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00787904 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells — 3.6; 1.8 percentage of CD3 positive cells
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Atlanta VA Medical Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells |
3.6; 1.8 | — |
| PRIMARY Percent Change in Thymus Size Measured by CT Scan |
-7; 17 | — |
| SECONDARY Bone Mineral Density |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00787904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.