Evaluation of the Spry Belt for Improving Bone Quality
Primary Purpose
Osteopenia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spry Belt
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia focused on measuring Low bone mass, Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Female
- Had her last menstrual period at least one year prior to the time of study enrollment
- Has low bone mass as defined by a DXA T-score between -1.0 and -2.49 for the femoral neck, proximal femur, total femur, or lumbar spine
- Is 50 years of age or older
- Can walk and stand without an assistive device
- Is able to provide informed consent
- Is able to understand spoken and written English
- Is capable and willing to follow all study-related procedures
Exclusion Criteria:
- Has a bone mineral density (BMD) at the femoral neck, proximal femur, total femur, or lumbar spine of T score ≤ -2.5 (defined by DXA)
- Has a 10-year probability of major fracture >20% or hip fracture >3% based on results of the Fracture Risk Assessment (FRAX) Tool
- Is currently taking or has taken bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone in the past 3 months
- Has had at least one fracture or at least one major surgery within the past 6 months
- Smokes >10 cigarettes per day over the past 6 months
- Has had an average of 14 alcoholic drinks per week over the past 6 months
- Has type I diabetes
- Has a history of severe renal disease or kidney failure
- Has had gastric bypass surgery
- Has been diagnosed with chronic renal disease, cirrhosis, multiple myeloma, neuromuscular disease, osteomalacia, Paget's disease, osteogenesis imperfecta, severe osteoarthritis, rheumatoid arthritis, severe peripheral neuropathy, gastrointestinal malabsorption or sprue, an eating disorder (e.g., anorexia nervosa, bulimia), uncontrolled hypertension, or chronic diseases known to affect the musculoskeletal system (e.g., muscular dystrophy)
- Has been diagnosed with an endocrine disorder known to adversely affect bone density, such as hyperparathyroidism, hyperthyroidism, or Cushing's syndrome
- Has cancer and/or is being treated for cancer
- Has had a bilateral oophorectomy
- Is being treated for a herniated disc
- Has had any prolonged immobilization (i.e., bedrest) for over one week or non-weight bearing for greater than one month of the axial or lower appendicular skeleton within the last 3 years
- Is engaged in high-impact activity at least three times per week (including but not limited to tennis, aerobics, running, weight-bearing activity or exercise more intense than fast walking).
- Has a known allergy to neoprene
- Has a hip circumference >56 inches
- Has a BMI > 35
Has abnormal results for the following laboratory tests:
- Serum 25(OH)D outside of the range: 10-100 ng/mL
- Serum calcium outside of the range: 8.9-10.3 mg/dL
- Serum PTH outside of the range: 12-88 pg/mL
- TSH outside of the range: 0.4 - 5.0 mIU/L (Note: If lab results are abnormal, subjects may see their MD to have thyroid medication adjusted and may be re-screened. If results are within the normal range, they may proceed with enrollment.)
- FSH less than 40 (mIU/L) (Note: FSH will be analyzed to confirm menopause, when necessary, such as in cases where women have had a history of hysterectomy and unilateral oophorectomy.)
- Has joint replacement implants in the ankle, knee, or hip
- Has had a spinal fusion procedure
- Has an active implant (e.g. implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks
- Has had a major change in high-impact physical activity level (increase or decrease) in the past 3 months
- Has undergone or is undergoing transgender hormone therapy
- Is deemed unsuitable for enrollment in the study by the Principal Investigator
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active
Sham
Arm Description
Subjects in this group will receive the active treatment for each daily treatment session.
Subjects in this group will receive the sham treatment for each daily treatment session.
Outcomes
Primary Outcome Measures
Vertebral body strength
Change in lumbar vertebral body strength as estimated via finite element analysis from CT scan data. A higher value indicates higher strength.
Number of device-related adverse events present
Safety assessment via device-related adverse events
Secondary Outcome Measures
Vertebral body bone mineral density
Change in lumber vertebral body areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.
Femoral bone mineral density
Change in femoral areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.
Full Information
NCT ID
NCT03986203
First Posted
June 11, 2019
Last Updated
April 4, 2022
Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Aging (NIA), University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT03986203
Brief Title
Evaluation of the Spry Belt for Improving Bone Quality
Official Title
Evaluation of the Spry Belt for Improving Bone Quality
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Aging (NIA), University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt. The Spry Belt is intended to deliver energy to the user's skeleton to reduce the progression of age-related decrease in bone quality in postmenopausal women. Half of the participants will receive the active treatment, while the other half will receive the sham/placebo treatment.
Detailed Description
Women lose a significant amount of bone after menopause and are at high risk of breaking bones. Bone cells have been shown to be responsive to different forms of applied energy, which can be used to reduce the progression of age-related declines in bone properties. The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt when used regularly over one year. The Spry Belt, a medical device that is worn around the hips like a belt, provides energy to the user's skeleton with the goal of improving bone quality in postmenopausal women with osteopenia, or low bone mass.
In this randomized, controlled study, all participants will receive the Spry Belt for at-home use over the 12 month study. Participants will be randomized (1:1) to the active or sham/placebo treatment group and give a Spry Belt that is pre-programmed to deliver the corresponding therapy. Participants will self-administer treatment sessions at least 5 times per week for 12 months. The effectiveness of the Spry Belt treatment will be assessed via CT and DXA scans of the user's bones to evaluate changes in bone density and strength over the study duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
Low bone mass, Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Only the clinical site staff member who trains the subject will know the group assignment. All subsequent interactions with each subject will not be carried out by the trainer.
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Subjects in this group will receive the active treatment for each daily treatment session.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subjects in this group will receive the sham treatment for each daily treatment session.
Intervention Type
Device
Intervention Name(s)
Spry Belt
Intervention Description
The Spry Belt delivers energy to the user that may help prevent bone loss. Participants will wear the device for 30 minutes a day, 5 days a week for one year. The active and sham devices are identical except for the specific energy that is delivered to the user.
Primary Outcome Measure Information:
Title
Vertebral body strength
Description
Change in lumbar vertebral body strength as estimated via finite element analysis from CT scan data. A higher value indicates higher strength.
Time Frame
Change from baseline to 12 months
Title
Number of device-related adverse events present
Description
Safety assessment via device-related adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Vertebral body bone mineral density
Description
Change in lumber vertebral body areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.
Time Frame
Change from baseline to 12 months
Title
Femoral bone mineral density
Description
Change in femoral areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.
Time Frame
Change from baseline to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Had her last menstrual period at least one year prior to the time of study enrollment
Has low bone mass as defined by a DXA T-score between -1.0 and -2.49 for the femoral neck, proximal femur, total femur, or lumbar spine
Is 50 years of age or older
Can walk and stand without an assistive device
Is able to provide informed consent
Is able to understand spoken and written English
Is capable and willing to follow all study-related procedures
Exclusion Criteria:
Has a bone mineral density (BMD) at the femoral neck, proximal femur, total femur, or lumbar spine of T score ≤ -2.5 (defined by DXA)
Has a 10-year probability of major fracture >20% or hip fracture >3% based on results of the Fracture Risk Assessment (FRAX) Tool
Is currently taking or has taken bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone in the past 3 months
Has had at least one fracture or at least one major surgery within the past 6 months
Smokes >10 cigarettes per day over the past 6 months
Has had an average of 14 alcoholic drinks per week over the past 6 months
Has type I diabetes
Has a history of severe renal disease or kidney failure
Has had gastric bypass surgery
Has been diagnosed with chronic renal disease, cirrhosis, multiple myeloma, neuromuscular disease, osteomalacia, Paget's disease, osteogenesis imperfecta, severe osteoarthritis, rheumatoid arthritis, severe peripheral neuropathy, gastrointestinal malabsorption or sprue, an eating disorder (e.g., anorexia nervosa, bulimia), uncontrolled hypertension, or chronic diseases known to affect the musculoskeletal system (e.g., muscular dystrophy)
Has been diagnosed with an endocrine disorder known to adversely affect bone density, such as hyperparathyroidism, hyperthyroidism, or Cushing's syndrome
Has cancer and/or is being treated for cancer
Has had a bilateral oophorectomy
Is being treated for a herniated disc
Has had any prolonged immobilization (i.e., bedrest) for over one week or non-weight bearing for greater than one month of the axial or lower appendicular skeleton within the last 3 years
Is engaged in high-impact activity at least three times per week (including but not limited to tennis, aerobics, running, weight-bearing activity or exercise more intense than fast walking).
Has a known allergy to neoprene
Has a hip circumference >56 inches
Has a BMI > 35
Has abnormal results for the following laboratory tests:
Serum 25(OH)D outside of the range: 10-100 ng/mL
Serum calcium outside of the range: 8.9-10.3 mg/dL
Serum PTH outside of the range: 12-88 pg/mL
TSH outside of the range: 0.4 - 5.0 mIU/L (Note: If lab results are abnormal, subjects may see their MD to have thyroid medication adjusted and may be re-screened. If results are within the normal range, they may proceed with enrollment.)
FSH less than 40 (mIU/L) (Note: FSH will be analyzed to confirm menopause, when necessary, such as in cases where women have had a history of hysterectomy and unilateral oophorectomy.)
Has joint replacement implants in the ankle, knee, or hip
Has had a spinal fusion procedure
Has an active implant (e.g. implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks
Has had a major change in high-impact physical activity level (increase or decrease) in the past 3 months
Has undergone or is undergoing transgender hormone therapy
Is deemed unsuitable for enrollment in the study by the Principal Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bilek, PT, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Spry Belt for Improving Bone Quality
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