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

NCT05457036 | Completed FDA Device

• 2 other identifiers: CRD-09-1471SB1AG046005
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteopenia; Low Bone Density

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Secondary Safety Endpoint

  12 weeks

• DXA-based Lumbar Spine Bone Mineral Density (aBMD)

  12 weeks

• DXA-based Total Femur Bone Mineral Density (aBMD)

  12 weeks

• Serum amino-terminal propeptide of type 1 procollagen (P1NP)

  12 weeks

• Serum N-telopeptide (sNTX)

  12 weeks

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

Active Treatment device device provides gentle energy to the lower spine and hips.

Device: Spry Belt

Sham Treatment Group

SHAM COMPARATOR

Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy.

Device: Sham Spry Belt

Interventions

Spry Belt DEVICE

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.

Active Treatment Group

Sham Spry Belt DEVICE

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.

Sham Treatment Group

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Female who had her last menstrual period at least one year prior to the time of study enrollment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bone Health Technologies, Inc.: lead
• University of Nebraska: collaborator
• University of California, San Francisco: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Northern California Institute for Research and Education (NCIRE)

San Francisco, California, 94121-1563, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7835, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Derek Hillstrom

  Bone Health Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Research staff will not change any study procedures based on the subject's group placement. Blinding assessment will be done during the study visits 2 and 3. We will use an established blinding assessment.33 Subjects will be asked if they believe they are receiving the real treatment, sham/placebo treatment, or if they are uncertain. Answers will be asked and recorded by the research staff on the case report forms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After signing the Study consent form, the subject will be randomized (1:1, block randomization with a block size of 10 stratified by site and race (Caucasian or non-Caucasian)) to one treatment group (Active or Sham treatment, see below) and be considered part of the intent-to-treat (ITT) cohort.

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: September 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 10, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)