Clinical trial NCT05457036: Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile
Official title: Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Low Bone Density
Lead sponsor: Bone Health Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
name: University of California, San Francisco
name: National Institute on Aging (NIA)
First posted: 2022-07-13
Enrollment: 94
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline for Urinary N-telopeptide (uNTX)
timeFrame: 6 weeks
measure: Adverse Event Safety Endpoint
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 12 weeks
measure: DXA-based Lumbar Spine Bone Mineral Density (aBMD)
timeFrame: 12 weeks
measure: DXA-based Total Femur Bone Mineral Density (aBMD)
timeFrame: 12 weeks
measure: Serum amino-terminal propeptide of type 1 procollagen (P1NP)
timeFrame: 12 weeks
measure: Serum N-telopeptide (sNTX)
timeFrame: 12 weeks
measure: Urine N-telopeptide (uNTX)
timeFrame: 12 weeks
measure: Serum cross-linked C-telopeptide of type I collagen (sCTX)
timeFrame: 12 weeks
measure: Quality of Life (QoL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Northern California Institute for Research and Education (NCIRE)
state: California
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: Bone Health Technologies
name: Derek Hillstrom
role: STUDY_DIRECTOR
References: