Trial Outcomes & Findings for Role of T-cells in Post-Menopausal Osteoporosis (NCT NCT00787904)

NCT ID: NCT00787904

Last Updated: 2016-12-13

Results Overview

(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)

• Recruitment status: COMPLETED
• Target enrollment: 19 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2016-12-13

Participant Flow

Participant milestones

Measure	Surgical Menopause Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal	Surgical Control Pre-menopausal women with or without surgery
Overall Study STARTED	6	13
Overall Study COMPLETED	6	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of T-cells in Post-Menopausal Osteoporosis

Baseline characteristics by cohort

Measure	Surgical Menopause n=6 Participants Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal	Surgical Control n=13 Participants Pre-menopausal women undergoing abdominal surgery but without ovary removal	Total n=19 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 5.1 • n=5 Participants	41.4 years STANDARD_DEVIATION 7.1 • n=7 Participants	42.9 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)

Outcome measures

Measure	Surgical Menopause n=6 Participants Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal	Surgical Control n=13 Participants Pre-menopausal women undergoing abdominal surgery but without ovary removal
Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells	3.6 percentage of CD3 positive cells Standard Deviation 0.5	1.8 percentage of CD3 positive cells Standard Deviation 0.2

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Surgical Menopause n=6 Participants Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal	Surgical Control n=13 Participants Pre-menopausal women undergoing abdominal surgery but without ovary removal
Percent Change in Thymus Size Measured by CT Scan	-7 percent change Standard Deviation 2	17 percent change Standard Deviation 4

SECONDARY outcome

Timeframe: 2 years

Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences

Outcome measures

Outcome data not reported

Adverse Events

Surgical Menopause

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgical Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vin Tangpricha

Emory University

Phone: 404-727-7254

Email: vin.tangpricha@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place