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=5 Participants	16.2 years STANDARD_DEVIATION 1.8 • n=7 Participants	16.3 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	1 Participants n=5 Participants	1 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	20 Participants n=7 Participants	38 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
Region of Enrollment United States	20 participants n=5 Participants	21 participants n=7 Participants	41 participants n=5 Participants
BMI Z-score	-2.34 Z-score STANDARD_DEVIATION 1.6 • n=5 Participants	-3.24 Z-score STANDARD_DEVIATION 2.66 • n=7 Participants	-2.79 Z-score STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 5 days

Outcome 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 days

Outcome 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

Dr. Amy DiVasta, PI

Boston Children's Hospital

Phone: 6173553792

Email: amy.divasta@childrens.harvard.edu

Results disclosure agreements

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