OsteopeniaNCT03986203
Evaluation of the Spry Belt for Improving Bone Quality
A study testing Spry Belt in people with Osteopenia, run by Theranova, L.L.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Spry Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Conditions
- Osteopenia
- Being tested
- Spry Belt
- Keywords
- Low bone mass, Osteoporosis
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spry BeltDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Subjects in this group will receive the active treatment for each daily treatment session. Receives: Device: Spry Belt |
| Sham | Sham comparator | Subjects in this group will receive the sham treatment for each daily treatment session. Receives: Device: Spry Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12 months
Number of device-related adverse events present
Safety assessment via device-related adverse events
Measured: 12 months
Secondary outcomes (2)
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.
Measured: Change from baseline to 12 months
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.
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start13 Aug 2019
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Laura Bilek, PT, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986203
- Sponsor's protocol ID
- CRD-09-1257
- Other IDs
- R44AG046005
- Status last verified
- Apr 2022
- First submitted
- 11 Jun 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Spry Belt for Improving Bone Quality
- ClinicalTrials.gov ID
- NCT03986203
- Acronym / sponsor ID
- CRD-09-1257
- Conditions
- Osteopenia
- Keywords
- Low bone mass, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Nebraska
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Spry BeltSubjects in this group will receive the active treatment for each daily treatment session. |
| Sham | Sham comparator | Device: Spry BeltSubjects in this group will receive the sham treatment for each daily treatment session. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spry BeltThe 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. | Device | Active, Sham |
Primary outcome
Vertebral body strength
Time frame: Change from baseline to 12 months
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
Time frame: 12 months
Safety assessment via device-related adverse events
2 secondary outcomes
Vertebral body bone mineral density
Time frame: Change from baseline to 12 months
Femoral bone mineral density
Time frame: Change from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Bilek, PT, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spry Belt in people with Osteopenia, run by Theranova, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertebral body strength (time frame: Change from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.