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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Magnitude Mechanical Stimulation | Experimental | 10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform. |
|
| Sham Low Magnitude Mechanical Stimulation | Placebo Comparator | 10 minutes daily of placebo treatment using a sham vibrating platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Magnitude Mechanical Stimulation | Device | Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distal Tibia Bone Quality | 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. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix W Wehrli, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Not all subjects enrolled (consented at screening visit) were randomized (randomized to intervention)
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Magnitude Mechanical Stimulation | 10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform. Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g. |
| FG001 | Sham Low Magnitude Mechanical Stimulation | 10 minutes daily of placebo treatment using a sham vibrating platform. Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Magnitude Mechanical Stimulation | 10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform. Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g. |
| BG001 | Sham Low Magnitude Mechanical Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Distal Tibia Bone Quality | 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. | Posted | Mean | 80% Confidence Interval | percentage of change | Baseline to 12 months |
|
Adverse event data was collected over five years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Magnitude Mechanical Stimulation | 10 minutes daily of 30 Hz/0.3g stimulation using a vibrating platform. Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment | Mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felix W. Wehrli, Principal Investigator | University of Pennsylvania Perelman School of Medicine | 215-662-7951 | felix.wehrli@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 24, 2018 | Sep 19, 2019 | Prot_SAP_ICF_000.pdf |
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| Sham Low Magnitude Mechanical Stimulation | Device | Mechanical stimulation for 10 minutes daily for 12 months using a sham device. |
|
| Physician Decision |
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| Withdrawal by Subject |
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| Subject missed final imaging |
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10 minutes daily of placebo treatment using a sham vibrating platform. Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 0 |
| 42 |
| 0 |
| 42 |
| 8 |
| 42 |
| EG001 | Sham Low Magnitude Mechanical Stimulation | 10 minutes daily of placebo treatment using a sham vibrating platform. Sham Low Magnitude Mechanical Stimulation: Mechanical stimulation for 10 minutes daily for 12 months using a sham device. | 0 | 38 | 0 | 38 | 2 | 38 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Mild |
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| Fatigue | General disorders | Non-systematic Assessment | Mild |
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| Itching/Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild |
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| Heavy Feeling in Bones | General disorders | Non-systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Mild |
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