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

Bone Health Technologies, Inc.

Status

Completed

Conditions

Osteopenia

Low Bone Density

Treatments

Device: Sham Spry Belt

Device: Spry Belt

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT05457036

SB1AG046005 (U.S. NIH Grant/Contract)

CRD-09-1471

Details and patient eligibility

About

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.

Full 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).

Enrollment

94 patients

Sex

Female

Ages

50+ years old

Volunteers

No 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, 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