Osteopenia Clinical Trial
Official title:
Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study
Verified date | May 2024 |
Source | Bone Health Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | December 10, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Northern California Institute for Research and Education (NCIRE) | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Bone Health Technologies, Inc. | National Institute on Aging (NIA), University of California, San Francisco, University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline for Urinary N-telopeptide (uNTX) | The percent change from Baseline for both Active and Sham treatment groups compared with a two-sample t-test with a significance level of 0.05. | 6 weeks | |
Primary | Adverse Event Safety Endpoint | Adverse Events as recorded on the Adverse Event Case Report Form, showing number and type of Serious Adverse Events and Device Related-Adverse Events compared between the Active and Sham groups | 12 weeks | |
Secondary | Secondary Safety Endpoint | The prevalence and severity of all side effects, as measured via the Adverse Event Checklist, will be compared between the Active and Sham groups. We will perform separate sub-comparisons for side effects that subjects' report as likely to be due to Spry Belt treatment and for those that are not. | 12 weeks | |
Secondary | DXA-based Lumbar Spine Bone Mineral Density (aBMD) | For each subject, aBMD for the lumbar spine (L1-L4 vertebrae) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05. | 12 weeks | |
Secondary | DXA-based Total Femur Bone Mineral Density (aBMD) | For each subject, aBMD for the total femur (average of left and right femurs) will be calculated at Baseline and 12 weeks (Study Completion). The percent change in aBMD will then be calculated for each subject. Results for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05. | 12 weeks | |
Secondary | Serum amino-terminal propeptide of type 1 procollagen (P1NP) | For each subject, sP1NP samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sP1NP will then be calculated for each subject. | 12 weeks | |
Secondary | Serum N-telopeptide (sNTX) | For each subject, sNTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sNTX will then be calculated for each subject. | 12 weeks | |
Secondary | Urine N-telopeptide (uNTX) | In addition to the primary endpoint, percent change in uNTX will be calculated for each subject from Baseline and 12 weeks (Visit #3, Study Completion). | 12 weeks | |
Secondary | Serum cross-linked C-telopeptide of type I collagen (sCTX) | For each subject, sCTX samples will be collected at Baseline, 6 weeks (Visit #2), and 12 weeks (Visit #3, Study Completion). The percent change in sCTX will then be calculated for each subject. | 12 weeks | |
Secondary | Quality of Life (QoL) | SF-12 will be used to evaluate QoL. For each subject, the SF-12 scores will be calculated at Baseline and 12 weeks (Study Completion). Change in SF-12 score for the Active and Sham groups will be compared using a with a two-sample t-test with a significance level of 0.05. | 12 weeks |
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