OsteopeniaNCT05457036
Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile
A study testing Spry Belt in people with Osteopenia and Low Bone Density, run by Bone Health Technologies, Inc. at 2 sites in United States.
Trial summary
To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period. The investigators will calculate the percentage and absolute changes from baseline for several BTMs for both the active and sham treatment groups. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteopenia, Low Bone Density
- 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
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2022to 10 Dec 2023
- 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
- No healthy volunteers
- 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, 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, 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 (at screening)
- Is currently taking or has taken oral bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, dehydroepiandrosterone, tenofovir disoproxil fumarate, 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 bariatric 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 primary hyperparathyroidism, hyperthyroidism, or Cushing's syndrome, unless definitively treated
- 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 normal laboratory ranges
- Serum PTH outside of the normal laboratory ranges
- TSH outside of the normal laboratory ranges*
- FSH less than 40 (mIU/L) **
- 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
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7835
Northern California Institute for Research and Education (NCIRE)
San Francisco, California, 94121-1563
About this study
Official title: Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study
To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period. The investigators will calculate the percentage and absolute changes from baseline for several BTMs for both the active and sham treatment groups.
Read the detailed description
This will be a 12-week, randomized, controlled study with 90 subjects. At enrollment, subjects will be randomized to the Active Treatment or Sham Treatment. All subjects will receive dietary supplements (calcium and vitamin D) for the duration of the study. Subjects will be asked to self-administer daily at-home treatments with the device at least 5 times each week. The investigators will evaluate safety via adverse events reported to the research staff and via responses to a survey on potential side effects. DXA scans will be obtained at the Screening Visit and Visit 3 (Study Completion). Blood and urine will be collected at Day 0 (Visit 1), Week 6 (Visit 2), and Week 12 (Visit 3).
- Conditions
- Osteopenia, Low Bone Density
- Being tested
- Spry Belt, Sham Spry Belt
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spry BeltDevice
The Spry Belt is a device worn around the hips which delivers gentle energy to the lower back. The level of energy is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The energy is at a level that may or may not be perceptible to the user. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via Bluetooth Low Energy (BLE)) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.
Sham Spry BeltDevice
The Sham Spry Belt is a device worn around the hips which does not deliver gentle energy to the lower back. The device instead provides a clicking noise similar to a motor. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via BLE) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | Active Treatment device device provides gentle energy to the lower spine and hips. Receives: Device: Spry Belt |
| Sham Treatment Group | Sham comparator | Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy. Receives: Device: Sham Spry Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for Urinary N-telopeptide (uNTX)
The percent change from Baseline for both Active and Sham treatment groups compared with a two-sample t-test with a significance level of 0.05.
Measured: 6 weeks
Adverse Event Safety Endpoint
Adverse Events as recorded on the Adverse Event Case Report Form, showing number and type of Serious Adverse Events and Device Related-Adverse Events compared between the Active and Sham groups
Measured: 12 weeks
Secondary outcomes (8)
Secondary Safety Endpoint
The prevalence and severity of all side effects, as measured via the Adverse Event Checklist, will be compared between the Active and Sham groups. We will perform separate sub-comparisons for side effects that subjects' report as likely to be due to Spry Belt treatment and for those that are not.
Measured: 12 weeks
DXA-based Lumbar Spine Bone Mineral Density (aBMD)
For each subject, aBMD for the lumbar spine (L1-L4 vertebrae) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.
Measured: 12 weeks
DXA-based Total Femur Bone Mineral Density (aBMD)
For each subject, aBMD for the total femur (average of left and right femurs) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.
Measured: 12 weeks
Serum amino-terminal propeptide of type 1 procollagen (P1NP)
For each subject, sP1NP samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sP1NP will then be calculated for each subject.
Measured: 12 weeks
Serum N-telopeptide (sNTX)
For each subject, sNTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sNTX will then be calculated for each subject.
Measured: 12 weeks
Urine N-telopeptide (uNTX)
In addition to the primary endpoint, percent change in uNTX will be calculated for each subject from Baseline and 12 weeks (Visit #3, Study Completion).
Measured: 12 weeks
Serum cross-linked C-telopeptide of type I collagen (sCTX)
For each subject, sCTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sCTX will then be calculated for each subject.
Measured: 12 weeks
Quality of Life (QoL)
SF-12 will be used to evaluate QoL. For each subject, the SF-12 scores will be calculated at Baseline and 12 weeks (Study Completion). Change in SF-12 score for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Oct 2023
- Study completion10 Dec 2023
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
- Model description
- After signing the Study consent form, the subject will be randomized (1:1, block randomization with a block size of 10 stratified by site and race (Caucasian or non-Caucasian)) to one treatment group (Active or Sham treatment, see below) and be considered part of the intent-to-treat (ITT) cohort.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Health Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska, University of California, San Francisco, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Derek Hillstrom, Study director, Bone Health Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457036
- Sponsor's protocol ID
- CRD-09-1471
- Other IDs
- SB1AG046005
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2022
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05457036
- Acronym / sponsor ID
- CRD-09-1471
- Conditions
- Osteopenia, Low Bone Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bone Health Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska, University of California, San Francisco, National Institute on Aging (NIA)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 13 Jul 2022 (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.
To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period. The investigators will calculate the percentage and absolute changes from baseline for several BTMs for both the active and sham treatment groups.
Detailed description
This will be a 12-week, randomized, controlled study with 90 subjects. At enrollment, subjects will be randomized to the Active Treatment or Sham Treatment. All subjects will receive dietary supplements (calcium and vitamin D) for the duration of the study. Subjects will be asked to self-administer daily at-home treatments with the device at least 5 times each week. The investigators will evaluate safety via adverse events reported to the research staff and via responses to a survey on potential side effects. DXA scans will be obtained at the Screening Visit and Visit 3 (Study Completion). Blood and urine will be collected at Day 0 (Visit 1), Week 6 (Visit 2), and Week 12 (Visit 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- After signing the Study consent form, the subject will be randomized (1:1, block randomization with a block size of 10 stratified by site and race (Caucasian or non-Caucasian)) to one treatment group (Active or Sham treatment, see below) and be considered part of the intent-to-treat (ITT) cohort.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Device: Spry BeltActive Treatment device device provides gentle energy to the lower spine and hips. |
| Sham Treatment Group | Sham comparator | Device: Sham Spry BeltSham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not 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, 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, 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 (at screening)
- Is currently taking or has taken oral bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, dehydroepiandrosterone, tenofovir disoproxil fumarate, 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 is a device worn around the hips which delivers gentle energy to the lower back. The level of energy is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The energy is at a level that may or may not be perceptible to the user. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via Bluetooth Low Energy (BLE)) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months. | Device | Active Treatment Group |
| Sham Spry BeltThe Sham Spry Belt is a device worn around the hips which does not deliver gentle energy to the lower back. The device instead provides a clicking noise similar to a motor. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via BLE) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months. | Device | Sham Treatment Group |
Primary outcome
Change from baseline for Urinary N-telopeptide (uNTX)
Time frame: 6 weeks
The percent change from Baseline for both Active and Sham treatment groups compared with a two-sample t-test with a significance level of 0.05.
Adverse Event Safety Endpoint
Time frame: 12 weeks
Adverse Events as recorded on the Adverse Event Case Report Form, showing number and type of Serious Adverse Events and Device Related-Adverse Events compared between the Active and Sham groups
8 secondary outcomes
Secondary Safety Endpoint
Time frame: 12 weeks
DXA-based Lumbar Spine Bone Mineral Density (aBMD)
Time frame: 12 weeks
DXA-based Total Femur Bone Mineral Density (aBMD)
Time frame: 12 weeks
Serum amino-terminal propeptide of type 1 procollagen (P1NP)
Time frame: 12 weeks
Serum N-telopeptide (sNTX)
Time frame: 12 weeks
Urine N-telopeptide (uNTX)
Time frame: 12 weeks
Serum cross-linked C-telopeptide of type I collagen (sCTX)
Time frame: 12 weeks
Quality of Life (QoL)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- 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.
Derek Hillstrom study director
Bone Health Technologies
2 sites 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 and Low Bone Density, run by Bone Health Technologies, Inc. at 2 sites 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: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline for Urinary N-telopeptide (uNTX) (time frame: 6 weeks). 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 29 Aug 2024.