Evaluation of the Spry Belt for Improving Bone Quality

The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt. The Spry Belt is intended to deliver energy to the user's skeleton to reduce the progression of age-related decrease in bone quality in postmenopausal women. Half of the participants will receive the active treatment, while the other half will receive the sham/placebo treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteopenia
• Intervention / Treatment: Device: Spry Belt

Detailed Description

Women lose a significant amount of bone after menopause and are at high risk of breaking bones. Bone cells have been shown to be responsive to different forms of applied energy, which can be used to reduce the progression of age-related declines in bone properties. The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt when used regularly over one year. The Spry Belt, a medical device that is worn around the hips like a belt, provides energy to the user's skeleton with the goal of improving bone quality in postmenopausal women with osteopenia, or low bone mass.

In this randomized, controlled study, all participants will receive the Spry Belt for at-home use over the 12 month study. Participants will be randomized (1:1) to the active or sham/placebo treatment group and give a Spry Belt that is pre-programmed to deliver the corresponding therapy. Participants will self-administer treatment sessions at least 5 times per week for 12 months. The effectiveness of the Spry Belt treatment will be assessed via CT and DXA scans of the user's bones to evaluate changes in bone density and strength over the study duration.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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, proximal femur, 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, proximal femur, 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
• Is currently taking or has taken bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, 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 gastric bypass 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 hyperparathyroidism, hyperthyroidism, or Cushing's syndrome
• 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 range: 8.9-10.3 mg/dL
  • Serum PTH outside of the range: 12-88 pg/mL
  • TSH outside of the range: 0.4 - 5.0 mIU/L (Note: If lab results are abnormal, subjects may see their MD to have thyroid medication adjusted and may be re-screened. If results are within the normal range, they may proceed with enrollment.)
  • FSH less than 40 (mIU/L) (Note: FSH will be analyzed to confirm menopause, when necessary, such as in cases where women have had a history of hysterectomy and unilateral oophorectomy.)
• 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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active; Subjects in this group will receive the active treatment for each daily treatment session.	Device: Spry Belt; The Spry Belt delivers energy to the user that may help prevent bone loss. Participants will wear the device for 30 minutes a day, 5 days a week for one year. The active and sham devices are identical except for the specific energy that is delivered to the user.
SHAM_COMPARATOR: Sham; Subjects in this group will receive the sham treatment for each daily treatment session.	Device: Spry Belt; The Spry Belt delivers energy to the user that may help prevent bone loss. Participants will wear the device for 30 minutes a day, 5 days a week for one year. The active and sham devices are identical except for the specific energy that is delivered to the user.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertebral body strength	Change in lumbar vertebral body strength as estimated via finite element analysis from CT scan data. A higher value indicates higher strength.	Change from baseline to 12 months
Number of device-related adverse events present	Safety assessment via device-related adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertebral body bone mineral density	Change in lumber vertebral body areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.	Change from baseline to 12 months
Femoral bone mineral density	Change in femoral areal bone mineral density (BMD) as assessed via dual-energy x-ray absorptiometry (DXA) scan. A higher BMD value indicates higher bone density.	Change from baseline to 12 months

Collaborators and Investigators

• Sponsor: Theranova, L.L.C.
• Collaborators: National Institute on Aging (NIA); University of Nebraska

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2019
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Osteoporosis; Low bone mass
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: CRD-09-1257; R44AG046005 (NIH)

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