Micromechanical Modeling Using Low Magnitude Mechanical Stimulation
Condition: Bone Alteration
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Low Magnitude Mechanical Stimulation; Sham Low Magnitude Mechanical Stimulation
Intervention type(s): Device; Device
Intervention description(s): Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.; Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Biomechanics; Osteogenesis