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Energy Delivery Device
Evaluation of the Spry Belt for Improving Bone Quality
N/A
Waitlist Available
Led By Laura Bilek, PT, PhD
Research Sponsored by Theranova, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Summary
This trial tests the Spry Belt, a hip-worn device that sends energy to bones, on postmenopausal women with low bone mass. The goal is to see if it can improve bone quality by stimulating bone cells and reducing bone loss.
Eligible Conditions
- Osteopenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of device-related adverse events present
Vertebral body strength
Secondary study objectives
Femoral bone mineral density
Vertebral body bone mineral density
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Subjects in this group will receive the active treatment for each daily treatment session.
Group II: ShamPlacebo Group1 Intervention
Subjects in this group will receive the sham treatment for each daily treatment session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spry Belt
2022
N/A
~100
Find a Location
Who is running the clinical trial?
Theranova, L.L.C.Lead Sponsor
12 Previous Clinical Trials
369 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,195,131 Total Patients Enrolled
University of NebraskaOTHER
555 Previous Clinical Trials
1,145,246 Total Patients Enrolled
Laura Bilek, PT, PhDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
276 Total Patients Enrolled