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

Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia; Low Bone Density
• Intervention / Treatment: Device: Spry Belt; Device: Sham Spry Belt

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).

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121-1563
      • Northern California Institute for Research and Education (NCIRE)
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7835
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment Group; Active Treatment device device provides gentle energy to the lower spine and hips.	Device: Spry Belt; The Spry Belt is a device worn around the hips which delivers gentle energy to the lower back. The level of energy is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The energy 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 is designed to be used with its companion Spry app (via Bluetooth Low Energy (BLE)) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.
Sham Comparator: Sham Treatment Group; Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy.	Device: Sham Spry Belt; The Sham Spry Belt is a device worn around the hips which does not deliver gentle energy to the lower back. The device instead provides a clicking noise similar to a motor. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via BLE) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline for Urinary N-telopeptide (uNTX)	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.	6 weeks
Adverse Event Safety Endpoint	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint	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.	12 weeks
DXA-based Lumbar Spine Bone Mineral Density (aBMD)	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.	12 weeks
DXA-based Total Femur Bone Mineral Density (aBMD)	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.	12 weeks
Serum amino-terminal propeptide of type 1 procollagen (P1NP)	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.	12 weeks
Serum N-telopeptide (sNTX)	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.	12 weeks
Urine N-telopeptide (uNTX)	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).	12 weeks
Serum cross-linked C-telopeptide of type I collagen (sCTX)	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.	12 weeks
Quality of Life (QoL)	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.	12 weeks

Collaborators and Investigators

• Sponsor: Bone Health Technologies, Inc.
• Collaborators: National Institute on Aging (NIA); University of California, San Francisco; University of Nebraska
• Investigators: Study Director: Derek Hillstrom, Bone Health Technologies

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: CRD-09-1471; SB1AG046005 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No