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NCT01921517 · ClinicalTrials.gov registry record · NA
Micromechanical Modeling Using Low Magnitude Mechanical Stimulation
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT01921517: Completed NA study, sponsored by University of Pennsylvania.
NCT01921517 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 117 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921517, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Low Magnitude Mechanical Stimulation
- DEVICE Sham Low Magnitude Mechanical Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-09 |
| Est. Completion | 2019-06-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01921517
The ClinicalTrials.gov registry entry for NCT01921517 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Magnitude Mechanical Stimulation is the first listed.
NCT01921517 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01921517 about?
NCT01921517 is a clinical study titled "Micromechanical Modeling Using Low Magnitude Mechanical Stimulation". 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 produc...
What is the current status of trial NCT01921517?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2012-09. Estimated completion is 2019-06-20.
What interventions are being tested in trial NCT01921517?
The interventions under investigation include: Low Magnitude Mechanical Stimulation (DEVICE), Sham Low Magnitude Mechanical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT01921517?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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