Evaluation of the Spry Belt for Improving Bone Quality

TheraNova

Status

Unknown

Conditions

Osteopenia

Treatments

Device: Spry Belt

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT03986203

CRD-09-1257

R44AG046005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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