The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT (computed tomography) scans that were analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via dual x-ray absorptiometry with a bone mineral density T-score between -1.0 and -2.49.
- The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year).
- Fracture risk was not evaluated in the clinical study to support the indications for use, so it is not known how the treatment effects correlate with fracture risk.
- The clinical effects have been demonstrated only for those who used the device as indicated.
Functional Description
The Osteoboost is a device worn around the hips which delivers vibration to the lower back. The level of vibration is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The vibration 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 can operate and function on its own. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12 months.
Device Description
The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted to a belt made of nylon-covered neoprene (Figure 1). The fabric portion of the belt wraps around the hips. After the belt has been fastened with the Velcro closure, the vibration pack is then secured tightly against the lower back with a nylon strap that is buckled in the front and pulled tight by the patient. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum (Figure 2). A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. The device includes a pressure sensor under the foam pad to be sure the device has been fastened with adequate pressure to transmit the vibration correctly. In addition, the belt incorporates an accelerometer positioned at the iliac crest which measures the actual transmission of vibration to the skeleton. After belt placement and before the beginning of each treatment session, the Osteoboost performs the auto-calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibrated vibration magnitude is then provided for the entire 30-minute session (with re-calibration occurring at the beginning of the next treatment session). The calibration step typically takes 5-15 seconds. The device is available in three sizes and each size adjusts in belt length of up to approximately 10 inches. The size range will accommodate a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, patients are instructed to administer treatment during activities that involve standing and walking, such as getting ready in the morning, walking, walking the dog, and doing the dishes.
Clinical Trial Description & Results
Summary
In a 12-month triple-blind, randomized, sham-controlled clinical trial of postmenopausal women with Osteopenia, Osteoboost demonstrated a 0.48% reduction in bone strength for patients who used the device per the protocol, a statistically significant difference compared to the 2.84% reduction in bone strength for patients who used a sham, non-therapeutic version of the device per the protocol. The protocol required treatment a minimum of 3 days per week consistently throughout the year. Osteoboost also reduced loss of vertebral bone density as measured by CT scan, demonstrating a 0.29% reduction in patients who used the device, a statistically significant difference compared to the 1.97% reduction for patients who used the sham device.
Study Design
The primary effectiveness endpoint was a comparison of the mean percentage change in vertebral bone strength between the active treatment and sham control groups, as calculated at baseline and 12 months. Vertebral bone strength was calculated using VirtuOst, a software-only medical device that analyzes data in computed tomography (CT) scans to estimate bone mineral density, bone strength, and load-to-strength ratio for physician information. The first lumbar vertebrae (L1) volumetric CT was taken at baseline and at 12 months, from which finite element analysis was used to estimate vertebral bone strength. Safety was evaluated by adverse events. The enrolled subjects were followed for 12 months.
Subject Population and Baseline Demographics
The study enrolled post-menopausal female subjects aged 52-82 diagnosed with low bone mass (osteopenia) defined by a DXA T-score between -1.0 and -2.49. The majority of the subject population was Caucasian women (120/126; 95%), with only 6/126 (5%) non-Caucasian subjects.
A candidate was excluded from the study if she met ANY of the following conditions:
- Had osteoporosis, as defined by a bone mineral density (BMD) at the femoral neck total femur, or lumbar spine of T score ≤ -2.5 (defined by DXA)
- Had a 10-year probability of major fracture >20% or hip fracture >3% based on results of the Fracture Risk Assessment (FRAX) Tool
- Was currently taking or had 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
- Had had at least one fracture or at least one major surgery within the past 6 months
- Smoked >10 cigarettes per day over the past 6 months
- Had had an average of 14 alcoholic drinks per week over the past 6 months
- Had type I diabetes
- Had a history of severe renal disease or kidney failure
- Had had gastric bypass surgery
- Had 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)
- Had been diagnosed with an endocrine disorder known to adversely affect bone density, such as hyperparathyroidism, hyperthyroidism, or Cushing’s syndrome
- Had cancer and/or was being treated for cancer
- Had had a bilateral oophorectomy
- Was being treated for a herniated disc
- Had 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
- Was 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).
- Had a known allergy to neoprene
- Had a hip circumference >56 inches
- Had a Body Mass Index (BMI) > 35
- Had 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: 8.9-10.4 mg/dL
- Serum parathyroid hormone (PTH) outside of the range: 12-88 pg/mL
- Thyroid-stimulating hormone (TSH) outside of the range: 0.4 – 5.0 mIU/L
- Follicle-stimulating hormone (FSH) less than 40 (mIU/L)
- Had joint replacement implants in the ankle, knee, or hip
- Had had a spinal fusion procedure
- Had an active implant (e.g., implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks
- Had had a major change in high-impact physical activity level (increase or decrease) in the past 3 months
- Had undergone or was undergoing transgender hormone therapy
- Was deemed unsuitable for enrollment in the study by the Principal Investigator.
Subject Accountability
Of the 265 women who were screened, 126 women were enrolled in the study. All 126 subjects were randomized to either Active Treatment or Sham Control Treatment and were included in the intent to treat (ITT) population. Of the 126 subjects that were enrolled, 64 subjects in the Active Treatment group and 61 subjects in the Sham group received the allocated intervention and were included in the modified Intent to Treat (mITT) population. Of the 125 subjects in the mITT population, 60 subjects in the Active Treatment group and 50 subjects in the Sham group completed a CT scan at 12 months and were included in the Complete Cases (CC) population. Because treatment effectiveness requires a degree of compliance with the treatment regimen, analyses on the mITT population and a Per Protocol (PP) population were conducted for all endpoints. The PP population included all mITT subjects who completed an average of at least 3 sessions per week of at least 24 minutes of total device use per day over the 12-month study. The number of subjects included in the PP analysis was 73/126, with 39/73 subjects in the Active treatment group and 34/73 in the Sham Control group.
Primary Endpoints
There were no statistically significant differences between the treatment groups of the primary analysis population (mITT).
However, additional analysis on the PP population demonstrated a 0.48% reduction in bone strength for subjects who used the device versus a 2.84% reduction in bone strength for subjects who used a sham, non-therapeutic version of the device. This reflects a modest, yet statistically significant 2.36% difference (p-value = 0.014) between the active treatment group and the control group for the PP population who used the device for at least 3 weekly sessions of 24 minutes each.
In the PP population, the treatment group lost 0.29% of their volumetric BMD (vBMD) as compared to the sham control group which lost 1.97% of their vBMD reflecting a statistically significant 1.68% difference (p-value = 0.008) in vBMD loss between the study groups. There was also a statistically significant 1.34% difference (p-value = 0.013) in vBMD loss observed between the active treatment group and the sham control group in the complete cases (CC) population.
The clinical relevance of these statistical differences has not been correlated with fracture risk and bone fragility.
Limitations of the clinical significance of the study data
- The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year).
- Fracture risk was not evaluated in the clinical study to support the indications for use, so it is not known how the treatment effects correlate with fracture risk.
- The clinical effects have been demonstrated only for those who used the device as indicated.
- In the clinical study of the device, a very high majority of Caucasian patients were evaluated (under-represented non-Caucasian population). Therefore, the effect of using the device in non-Caucasian population is not clearly demonstrated.
- The safety and effectiveness of the device has not been evaluated in patient populations with high-risk factors for developing bone fragility or fractures, such as heavy smoking, Type I diabetes, history of fractures, renal disease, and BMI > 35.
- Clinically relevant adverse effects include back pain, dizziness and muscle weakness.
Warnings
Please read all instructions carefully before use. Observe all warnings and precautions in this manual.
This device is not indicated for patients with osteoporosis.
Let your doctor know before use of the Osteoboost if you have any of the following conditions: 1) are allergic to neoprene, 2) are being treated for a herniated disc, 3) have had a spinal fusion procedure, 4) have a joint replacement implant in the ankle, knee, or hip, or 5) have an active implant (e.g. implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks.
This device has been evaluated in a clinical study with a high majority of Caucasian women without high-risk factors for developing bone fragility, such as heavy smoking, type I diabetes, renal disease, or a history of fractures. The safety and effectiveness of the device has not been evaluated in a significant number of non-Caucasian women, in subjects with high-risk factors for developing bone fragility, or in subjects with a BMI > 35.
Do not attempt to open, repair, or modify the unit or replace parts. Attempting to do so could result in bodily injury or harm. If the unit or any parts are not working, please contact Bone Health Technologies at (833)-GO-OSTEO / (833)-466-7836 (toll-free). Repairs should only be made by Bone Health Technologies authorized personnel.
Do not use the Osteoboost near external sources of vibration such as, but not limited to, washing machines.
Do not apply Osteoboost directly to the skin. Wear a thin layer of clothing between the device and the skin.
Do not attempt to insert any objects (other than the supplied charger), including bodily parts into any ports. Doing so could result in bodily injury or harm.
Do not clean the Osteoboost. If there is a minor spill on the Osteoboost, dab the area with a dry cloth. If a larger spill has occurred, dab the area with a dry cloth and contact Bone Health Technologies at (833)-GO-OSTEO / (833)-466-7836 (toll-free).
Avoid contact between the Osteoboost and water and/or fluids. Do not immerse or submerge the Osteoboost in water and/or fluids. If the Osteoboost gets wet, please discontinue use and notify Bone Health Technologies.
Do not use the Osteoboost if it shows obvious signs of damage. If damage occurs, please contact Bone Health Technologies at (833)-GO-OSTEO / (833)-466-7836 (toll-free).
Discontinue use and notify Bone Health Technologies if any of the following device problems occur:
- Device runs longer than 30 minutes
- Device is dropped and damage to belt or plastic enclosure occurs
- Abnormal noise or rattling is heard
- Device cannot be powered down manually (holding down power button)
- Device status is unclear: device shuts down randomly, “freezes”, etc.
- Device vibrations cause aches, pain, tenderness, or bruising at site of application
- Device vibrations cause dizziness/vertigo/motion sickness/headache
- Device material causes adverse skin reaction
Precautions
Handle the Osteoboost carefully. Do not drop.
Use the Osteoboost only as instructed by this manual and the separate instructions.
Ensure that the Osteoboost is worn as directed by this manual and the separate instructions. The Osteoboost should be tight, yet comfortable, on the body when worn. The Osteoboost will notify you when it is too loose.
Only charge the Osteoboost with the supplied charger.
Use caution when undoing the outer strap. As described in the instructions below, it is recommended that you undo the Velcro to release the tension on the strap before releasing the clasp.
Risks and Side Effects
Consult your doctor if you experience pain during or after use of the Osteoboost. Potential risks of therapeutic vibration include:
- Lower or upper back pain
- Leg or pelvic pain
- Aches, tenderness, or bruising at site of application
- Adverse skin reactions
Discontinue use and consult your doctor if you experience temporary side effects during or after use of the Osteoboost. Temporary side effects of therapeutic vibration with Osteoboost include:
- Muscle weakness
- Digestive or gastrointestinal issues
- Dizziness, loss of balance, vertigo, or motion sickness
- Blurred vision
- Headaches