Bone Alteration Clinical Trial
Official title:
Osteoporosis Treatment Response Assessed by Micromechanical Modeling of MRI Data
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.
Weightbearing exercise has an osteogenic effect by reducing bone resorption and enhancing
bone formation. During the past several years a number of articles have appeared
demonstrating that low-magnitude mechanical stimulation (LMMS) is osteogenic in animals and
also in humans. Preclinical studies have also demonstrated an effect of decrease in
adiposity. The mechanobiology underlying these phenomena is beginning to emerge in terms of
expression of genes stimulated by the action of the vibrations to which osteocytes and
adipocytes are subjected.
If successful, LMMS treatment, a non-pharmacologic intervention, could prevent bone loss and
potentially stimulate bone formation and decreased adipocyte production resulting in
increased bone strength and reduced fracture susceptibility in subjects at risk of developing
osteoporosis. The proposed project focuses directly on measures of strength by evaluating the
therapeutic response in terms of magnetic resonance (MR) image-based micro finite-element
(FE) assessment of bone stiffness and failure strength, along with quantifying
treatment-induced changes in marrow adiposity, as part of a single, integrated examination,
conducted at baseline and 12 months of treatment in a double-blinded, randomized,
placebo-controlled study of early postmenopausal women.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02375503 -
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|
N/A |