Clinical trial NCT03986203: Evaluation of the Spry Belt for Improving Bone Quality
Official title: Evaluation of the Spry Belt for Improving Bone Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteopenia
Keywords: Low bone mass
Osteoporosis
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: University of Nebraska
First posted: 2019-06-14
Enrollment: 140
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vertebral body strength
timeFrame: Change from baseline to 12 months
measure: Number of device-related adverse events present
timeFrame: 12 months
Secondary outcomes:
measure: Vertebral body bone mineral density
timeFrame: Change from baseline to 12 months
measure: Femoral bone mineral density
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Laura Bilek, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: