CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 117 enrolled
Drug / intervention
Low Magnitude Mechanical Stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01921517
NCT01921517N/ACompleted

Osteoporosis Treatment Response Assessed by Micromechanical Modeling of MRI Data

University of Pennsylvania·interventional·Posted Aug 13, 2013·Updated Nov 15, 2019

In Brief

A clinical study evaluating Low Magnitude Mechanical Stimulation and Sham Low Magnitude Mechanical Stimulation for Bone Alteration. Completed, enrolled 117 participants across 1 site.

Detailed Summary

The response to a daily 10 minute session of low-magnitude mechanical stimulation (LMMS) on bone in 100 postmenopausal women ages 45-65 years will be evaluated at baseline and 12 months using high-resolution magnetic resonance (MR) imaging. Subjects will be assigned to an active platform that produces vibrations or to a placebo platform that produces no vibrations. The investigators propose to evaluate the hypothesis that LMMS applied to postmenopausal women ages 45-65 improves the mechanical integrity of bone while lowering marrow adiposity. 1. The investigators will optimize an integrated imaging protocol for high-resolution structural MR imaging of the distal tibia and spectroscopic imaging-based quantification of bone marrow composition in the lumbar vertebrae. 2. The investigators will further develop and validate micro-finite-element (FE) analysis for quantitative assessment of trabecular and cortical bone stiffness and failure load from high-resolution MR images of the distal tibia. 3. The investigators will apply the methodology of Aims 1 and 2 (above) in a double-blinded, randomized, placebo-controlled study to a cohort of 100 healthy postmenopausal women in the age range of 45-65 years, studied at baseline and 12 months after having been subjected to 10 minutes daily of either 30 Hz/0.3g stimulation or placebo treatment, monitored rigorously via electronic feedback.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Alteration
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2013
Enrollment StartSep 1, 2012
Primary CompletionFeb 28, 2019
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 12.9 years ago

Interventions

Low Magnitude Mechanical Stimulationdevice

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 Stimulationdevice

Mechanical stimulation for 10 minutes daily for 12 months using a sham device.