Trial Outcomes & Findings for Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa (NCT NCT01100567)
NCT ID: NCT01100567
Last Updated: 2017-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
Baseline to 5 days
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
LMMS
Randomized to 10 min LMMS daily
|
Placebo
Randomized to sham platform 10 min daily
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
LMMS
Randomized to 10 min LMMS daily
|
Placebo
Randomized to sham platform 10 min daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Early Hospital Discharge
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Deemed ineligible after consent
|
0
|
1
|
Baseline Characteristics
Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
LMMS
n=20 Participants
Randomized to 10 min LMMS daily
|
Placebo
n=21 Participants
Randomized to sham platform 10 min daily
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
16.2 years
STANDARD_DEVIATION 1.8 • n=107 Participants
|
16.3 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
BMI Z-score
|
-2.34 Z-score
STANDARD_DEVIATION 1.6 • n=99 Participants
|
-3.24 Z-score
STANDARD_DEVIATION 2.66 • n=107 Participants
|
-2.79 Z-score
STANDARD_DEVIATION 2.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 daysOutcome measures
| Measure |
LMMS
n=20 Participants
Randomized to 10 min LMMS daily
|
Placebo
n=21 Participants
Randomized to sham platform 10 min daily
|
|---|---|---|
|
Change From Baseline in C-telopeptides
|
0.083 ng/mL/day
Interval 0.006 to 0.159
|
-0.027 ng/mL/day
Interval -0.119 to 0.065
|
SECONDARY outcome
Timeframe: baseline to 5 daysOutcome measures
| Measure |
LMMS
n=20 Participants
Randomized to 10 min LMMS daily
|
Placebo
n=21 Participants
Randomized to sham platform 10 min daily
|
|---|---|---|
|
Change From Baseline in Bone Specific Alkaline Phosphatase
|
-0.07 ug/L/day
Interval -0.26 to 0.14
|
-0.36 ug/L/day
Interval -0.68 to -0.04
|
Adverse Events
LMMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place