Evaluation of the Spry Belt for Improving Bone Quality

NCT03986203 | Unknown FDA Device

• 2 other identifiers: CRD-09-1257R44AG046005
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

Low bone mass; Osteoporosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Vertebral body bone mineral density

  Change from baseline to 12 months

• Femoral bone mineral density

  Change from baseline to 12 months

Study Arms (2)

Active

EXPERIMENTAL

Subjects in this group will receive the active treatment for each daily treatment session.

Device: Spry Belt

Sham

SHAM COMPARATOR

Subjects in this group will receive the sham treatment for each daily treatment session.

Device: Spry Belt

Interventions

Spry Belt DEVICE

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.

Active; Sham

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• 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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• National Institute on Aging (NIA): collaborator
• University of Nebraska: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Bilek, PT, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: August 13, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)