N/A
N=80
Micromechanical Modeling Using Low Magnitude Mechanical Stimulation
Bone Alteration
Bottom Line
View on ClinicalTrials.gov: NCT01921517 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Distal Tibia Bone Quality — 1.121; -2.141 percentage of change — p=0.0481
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Magnitude Mechanical Stimulation (Device); Sham Low Magnitude Mechanical Stimulation (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Distal Tibia Bone Quality |
1.121; -2.141 | 0.0481 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Females, ages 45-65 years and post menopausal, as defined by a history of amenorrhea for a minimum of 24 months and a serum FSH (follicle-stimulating hormone) concentration of 25 mIU/mL (milli-International unit per milliliter) and negative pregnancy test.
Exclusion Criteria
- Current or prior use of medications known to affect bone (e.g. bisphosphonates, calcitonin, selective estrogen receptor modulators, denosumab, diphenylhydantoin, recent systemic glucocorticoid use), bone mineral density T score of less than -2.5 and greater than +2, Vitamin D level less then 12 ng/ml, BMI (body mass index) of greater than 32, current alcohol or drug abuse: more than 3 alcoholic beverages per day or current abuse of illicit drugs or prescription medication, uncontrolled or untreated cardiac or pulmonary disease liver disease: history of hepatitis or ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than 2x ULN (upper limit of normal), renal disease: history of renal disease or serum creatinine greater than 2x ULN diabetes, pacemaker or metallic implants considered a contraindication to MR scanning.
Data sourced from ClinicalTrials.gov (NCT01921517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.