An interventional study of Spry Belt and Sham Spry Belt in Osteopenia and Low Bone Density, sponsored by Bone Health Technologies, Inc.. Completed at 2 sites in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Bone Health Technologies, Inc. · Not applicable, Interventional, and Treatment
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).
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's enrollment of 94 is above the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →This is the only study on the registry with Bone Health Technologies, Inc. as lead sponsor.
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Exclusion Criteria:
Active Treatment device device provides gentle energy to the lower spine and hips.
Device: Spry Belt
Sham Treatment device is identical to the Active Treatment device except the sham device does not produce the gentle energy.
Device: Sham Spry Belt
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.
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.
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.
Time frame: 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
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
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