N/A
N=18
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT03688282 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Percent Change in Blood-based Biomarker of Bone Loss — 8.8; -5.4 Percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wearable vibration belt (Device); Sham, wearing belt (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Theranova, L.L.C.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Blood-based Biomarker of Bone Loss |
8.8; -5.4 | <0.001 sig |
Summary
The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.
Eligibility Criteria
Inclusion Criteria
- Female
- Last menstrual period at least one year prior and not more than eight years prior.
- 19 years of age and older.
- BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
- Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).
- Able to understand spoken and written English.
- Capable and willing to follow all study-related procedures.
Exclusion Criteria
- BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
- A 10-year probability of hip fracture of > 3% or major fracture of > 20% based on results of DXA using the FRAX tool (see attached).
- Weight > 300 lbs.
- Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.
- Active cancer or cancer treatment.
- Any change in exercise in the past 3 months.
- Fractures or major surgery within the past 6 months.
- Medical Implants (excluding dental implants).
- Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.
- Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.
- Hip circumference is greater than 42 inches
Data sourced from ClinicalTrials.gov (NCT03688282). 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.