Trial Outcomes & Findings for Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2 (NCT NCT03688282)
NCT ID: NCT03688282
Last Updated: 2021-04-27
Results Overview
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.
COMPLETED
NA
18 participants
Baseline and 30 minutes after completing the 30-minute treatment session
2021-04-27
Participant Flow
Participant milestones
| Measure |
Sham & 30 Minute Treatment
Visit 1:
Device will be worn but not turned on. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Visit 2:
Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
|
|---|---|
|
Sham Treatment for 30 Minutes
STARTED
|
18
|
|
Sham Treatment for 30 Minutes
COMPLETED
|
17
|
|
Sham Treatment for 30 Minutes
NOT COMPLETED
|
1
|
|
Washout (7 Days)
STARTED
|
17
|
|
Washout (7 Days)
COMPLETED
|
17
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
|
Active Treatment for 30 Minutes
STARTED
|
17
|
|
Active Treatment for 30 Minutes
COMPLETED
|
17
|
|
Active Treatment for 30 Minutes
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Baseline characteristics by cohort
| Measure |
Sham & 30 Minute Treatment
n=18 Participants
Visit 1:
Device will be worn but not turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Visit 2:
Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
54.41 years
STANDARD_DEVIATION 4.77 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes after completing the 30-minute treatment sessionPopulation: All subjects that completed both treatment sessions
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.
Outcome measures
| Measure |
Sham Treatment Session
n=17 Participants
Device will be worn but not turned on (does not deliver the active treatment) for 30 minute treatment session.
|
Active Treatment Session
n=17 Participants
Device will be worn and turned on (delivers the active treatment) for 30 minute treatment session.
|
|---|---|---|
|
Percent Change in Blood-based Biomarker of Bone Loss
|
8.8 Percent change
Standard Deviation 7.6
|
-5.4 Percent change
Standard Deviation 8.8
|
Adverse Events
Sham Treatment Session
Active Treatment Session
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60