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Evaluation of the Spry Belt for Improving Bone Quality

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ClinicalTrials.gov Identifier: NCT03986203
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of Nebraska
Information provided by (Responsible Party):
Theranova, L.L.C.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteopenia Device: Spry Belt Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Only the clinical site staff member who trains the subject will know the group assignment. All subsequent interactions with each subject will not be carried out by the trainer.
Primary Purpose: Treatment
Official Title: Evaluation of the Spry Belt for Improving Bone Quality
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

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.




Primary Outcome Measures :
  1. Vertebral body strength [ Time Frame: Change from baseline to 12 months ]
    Change in lumbar vertebral body strength as estimated via finite element analysis from CT scan data. A higher value indicates higher strength.

  2. Number of device-related adverse events present [ Time Frame: 12 months ]
    Safety assessment via device-related adverse events


Secondary Outcome Measures :
  1. Vertebral body bone mineral density [ Time Frame: Change from baseline to 12 months ]
    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.

  2. Femoral bone mineral density [ Time Frame: Change from baseline to 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986203


Contacts
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Contact: Michael Vice President, PhD 415-926-8616 clinicalstudy@theranova.com

Locations
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United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Kara Research Project Coordinator    402-559-6584    beltstudy@unmc.edu   
Principal Investigator: Laura Bilek, PT, PhD         
Sponsors and Collaborators
Theranova, L.L.C.
National Institute on Aging (NIA)
University of Nebraska
Investigators
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Principal Investigator: Laura Bilek, PT, PhD University of Nebraska

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Responsible Party: Theranova, L.L.C.
ClinicalTrials.gov Identifier: NCT03986203     History of Changes
Other Study ID Numbers: CRD-09-1257
R44AG046005 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Theranova, L.L.C.:
Low bone mass
Osteoporosis

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases