Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-10

Brief Summary

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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.

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Detailed Description

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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

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Osteopenia Low Bone Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Research staff will not change any study procedures based on the subject's group placement. Blinding assessment will be done during the study visits 2 and 3. We will use an established blinding assessment.33 Subjects will be asked if they believe they are receiving the real treatment, sham/placebo treatment, or if they are uncertain. Answers will be asked and recorded by the research staff on the case report forms.

Study Groups

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Active Treatment Group

Active Treatment device device provides gentle energy to the lower spine and hips.

Group Type EXPERIMENTAL

Spry Belt

Intervention Type DEVICE

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 Treatment Group

Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy.

Group Type SHAM_COMPARATOR

Sham Spry Belt

Intervention Type DEVICE

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.

Interventions

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Spry Belt

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.

Intervention Type DEVICE

Sham Spry Belt

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.

Intervention Type DEVICE

Eligibility Criteria

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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, 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, 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
* 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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No