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

Not Applicable

Completed

Conditions: Osteopenia
Low Bone Density

Interventions: Device: Sham Spry Belt
Device: Spry Belt

Registration Number: NCT05457036

Lead Sponsor: Bone Health Technologies, Inc.

Brief Summary: 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.

Detailed 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 94

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Treatment Group	Sham Spry Belt	Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy.
Active Treatment Group	Spry Belt	Active Treatment device device provides gentle energy to the lower spine and hips.

Primary Outcome Measures

Name	Time	Method
Adverse Event Safety Endpoint	12 weeks	Adverse Events as recorded on the Adverse Event Case Report Form, showing number and type of Serious Adverse Events and Device Related-Adverse Events compared between the Active and Sham groups
Change from baseline for Urinary N-telopeptide (uNTX)	6 weeks	The percent change from Baseline for both Active and Sham treatment groups compared with a two-sample t-test with a significance level of 0.05.

Secondary Outcome Measures

Name	Time	Method
Urine N-telopeptide (uNTX)	12 weeks	In addition to the primary endpoint, percent change in uNTX will be calculated for each subject from Baseline and 12 weeks (Visit #3, Study Completion).
Serum amino-terminal propeptide of type 1 procollagen (P1NP)	12 weeks	For each subject, sP1NP samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sP1NP will then be calculated for each subject.
Serum cross-linked C-telopeptide of type I collagen (sCTX)	12 weeks	For each subject, sCTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sCTX will then be calculated for each subject.
DXA-based Total Femur Bone Mineral Density (aBMD)	12 weeks	For each subject, aBMD for the total femur (average of left and right femurs) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.
Secondary Safety Endpoint	12 weeks	The prevalence and severity of all side effects, as measured via the Adverse Event Checklist, will be compared between the Active and Sham groups. We will perform separate sub-comparisons for side effects that subjects' report as likely to be due to Spry Belt treatment and for those that are not.
DXA-based Lumbar Spine Bone Mineral Density (aBMD)	12 weeks	For each subject, aBMD for the lumbar spine (L1-L4 vertebrae) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.
Serum N-telopeptide (sNTX)	12 weeks	For each subject, sNTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sNTX will then be calculated for each subject.
Quality of Life (QoL)	12 weeks	SF-12 will be used to evaluate QoL. For each subject, the SF-12 scores will be calculated at Baseline and 12 weeks (Study Completion). Change in SF-12 score for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05.

Trial Locations

Locations (2): Northern California Institute for Research and Education (NCIRE)
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San Francisco, California, United States
University of Nebraska Medical Center
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Omaha, Nebraska, United States