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Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile | Clinical Trials | Clareo Health

COMPLETEDNA

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

Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study

NCT05457036•Bone Health Technologies, Inc.

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

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)
+21 more criteria

Locations (2)

Northern California Institute for Research and Education (NCIRE)

San Francisco, California, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Key Dates

Start Date

September 1, 2022

Primary Completion Date

October 31, 2023

Completion Date

December 10, 2023

Last Updated

August 29, 2024

Enrollment

ACTUAL participants

Conditions

OsteopeniaLow Bone Density

Interventions

Spry Belt

DEVICE

Sham Spry Belt

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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