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| ID | Type | Description | Link |
|---|---|---|---|
| SB1AG046005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Nebraska | OTHER |
| University of California, San Francisco | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Group | Experimental | Active Treatment device device provides gentle energy to the lower spine and hips. |
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| Sham Treatment Group | Sham Comparator | Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spry Belt | Device | The Spry Belt is a device worn around the hips which delivers gentle energy to the lower back. The level of energy is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The energy is at a level that may or may not be perceptible to the user. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via Bluetooth Low Energy (BLE)) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female who had her last menstrual period at least one year prior to the time of study enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Derek Hillstrom | Bone Health Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Institute for Research and Education (NCIRE) | San Francisco | California | 94121-1563 | United States | ||
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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After signing the Study consent form, the subject will be randomized (1:1, block randomization with a block size of 10 stratified by site and race (Caucasian or non-Caucasian)) to one treatment group (Active or Sham treatment, see below) and be considered part of the intent-to-treat (ITT) cohort.
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Research staff will not change any study procedures based on the subject's group placement. Blinding assessment will be done during the study visits 2 and 3. We will use an established blinding assessment.33 Subjects will be asked if they believe they are receiving the real treatment, sham/placebo treatment, or if they are uncertain. Answers will be asked and recorded by the research staff on the case report forms.
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| Sham Spry Belt | Device | The Sham Spry Belt is a device worn around the hips which does not deliver gentle energy to the lower back. The device instead provides a clicking noise similar to a motor. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via BLE) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| University of Nebraska Medical Center |
| Omaha |
| Nebraska |
| 68198-7835 |
| United States |