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
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). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Active, not recruiting |
NCT05066477 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women
|
N/A | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT01439139 -
Bone UltraSonic Scanner (BUSS): Validation Study
|
N/A | |
Not yet recruiting |
NCT01397838 -
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
|
Phase 1 | |
Completed |
NCT01222026 -
Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
|
Phase 4 | |
Completed |
NCT01152580 -
Melatonin Osteoporosis Prevention Study
|
Phase 1 | |
Completed |
NCT00789425 -
Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
|
Phase 2 | |
Completed |
NCT00655681 -
Prevention of Post Operative Bone Loss in Children
|
N/A | |
Completed |
NCT00463268 -
Osteoporosis Prevention With Low Dose Alendronate
|
Phase 3 | |
Completed |
NCT00798473 -
Zoledronate for Osteopenia in Pediatric Crohn's
|
Phase 3 | |
Active, not recruiting |
NCT00076050 -
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
|
Phase 3 | |
Completed |
NCT00226031 -
Optimal Management of Women With Wrist Fractures
|
N/A | |
Enrolling by invitation |
NCT04752098 -
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
|
N/A | |
Completed |
NCT04720833 -
Effect of Dried Plum on Bone and Markers of Bone Status in Men
|
N/A | |
Recruiting |
NCT05541432 -
Finding the Optimal Resistance Training Intensity For Your Bones
|
N/A | |
Active, not recruiting |
NCT05405894 -
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
|
||
Completed |
NCT04040010 -
The Effects of Bovine Colostrum in Bone Metabolism in Humans
|
N/A | |
Completed |
NCT02731820 -
Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia
|
N/A | |
Completed |
NCT05721014 -
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
|
N/A |