Trial Outcomes & Findings for Micromechanical Modeling Using Low Magnitude Mechanical Stimulation (NCT NCT01921517)
NCT ID: NCT01921517
Last Updated: 2019-11-15
Results Overview
Distal tibial bone quality is measured through MRI by calculating the ratio between bone volume to total volume. A lower value would indicate osteoporotic (weaker) bone; a higher value would indicate healthy (normal) bone.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2019-11-15
Participant Flow
Not all subjects enrolled (consented at screening visit) were randomized (randomized to intervention)
Participant milestones
| Measure |
Low Magnitude Mechanical Stimulation
10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.
Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
|
Sham Low Magnitude Mechanical Stimulation
10 minutes daily of placebo treatment using a sham vibrating platform.
Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
Low Magnitude Mechanical Stimulation
10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.
Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
|
Sham Low Magnitude Mechanical Stimulation
10 minutes daily of placebo treatment using a sham vibrating platform.
Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Newly diagnosed health concern
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Subject missed final imaging
|
1
|
4
|
Baseline Characteristics
Micromechanical Modeling Using Low Magnitude Mechanical Stimulation
Baseline characteristics by cohort
| Measure |
Low Magnitude Mechanical Stimulation
n=42 Participants
10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.
Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
|
Sham Low Magnitude Mechanical Stimulation
n=38 Participants
10 minutes daily of placebo treatment using a sham vibrating platform.
Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
38 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsDistal tibial bone quality is measured through MRI by calculating the ratio between bone volume to total volume. A lower value would indicate osteoporotic (weaker) bone; a higher value would indicate healthy (normal) bone.
Outcome measures
| Measure |
Low Magnitude Mechanical Stimulation
n=42 Participants
10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.
Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
|
Sham Low Magnitude Mechanical Stimulation
n=38 Participants
10 minutes daily of placebo treatment using a sham vibrating platform.
Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
|
|---|---|---|
|
Change in Distal Tibia Bone Quality
|
1.121 percentage of change
Interval -0.35 to 2.29
|
-2.141 percentage of change
Interval -4.53 to 0.25
|
Adverse Events
Low Magnitude Mechanical Stimulation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sham Low Magnitude Mechanical Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Magnitude Mechanical Stimulation
n=42 participants at risk
10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform.
Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
|
Sham Low Magnitude Mechanical Stimulation
n=38 participants at risk
10 minutes daily of placebo treatment using a sham vibrating platform.
Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
|
|---|---|---|
|
General disorders
Headache
|
4.8%
2/42 • Number of events 2 • Adverse event data was collected over five years.
|
0.00%
0/38 • Adverse event data was collected over five years.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected over five years.
|
0.00%
0/38 • Adverse event data was collected over five years.
|
|
General disorders
Fatigue
|
4.8%
2/42 • Number of events 2 • Adverse event data was collected over five years.
|
0.00%
0/38 • Adverse event data was collected over five years.
|
|
Skin and subcutaneous tissue disorders
Itching/Redness
|
4.8%
2/42 • Number of events 2 • Adverse event data was collected over five years.
|
0.00%
0/38 • Adverse event data was collected over five years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/42 • Adverse event data was collected over five years.
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected over five years.
|
|
General disorders
Heavy Feeling in Bones
|
0.00%
0/42 • Adverse event data was collected over five years.
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected over five years.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected over five years.
|
0.00%
0/38 • Adverse event data was collected over five years.
|
Additional Information
Felix W. Wehrli, Principal Investigator
University of Pennsylvania Perelman School of Medicine
Phone: 215-662-7951
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place