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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). 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.
Primary Outcome
Distal tibial bone quality is measured through MRI by calculating the ratio between bone volume to total volume. A lower value would indicate osteoporotic (weaker) bone; a higher value would indicate healthy (normal) bone.
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 |
What the finished NCT01921517 record still lists
NCT01921517 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Low Magnitude Mechanical Stimulation is the first listed.
NCT01921517 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921517's enrollment target sits among peer trials
117 807th of 2000 higher than 1,193 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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