Osteopenia Clinical Trial
Official title:
Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature infants who are at risk for bone disease.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | September 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Days to 8 Months |
Eligibility | Inclusion Criteria: - Full term newborns, approximately equal number of male and female newborn, age <28 days. - Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth <37 weeks or birth weight <1500 grams. Exclusion Criteria: - Infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past. - Infants with major congenital anomalies that may affect bone health or structure. - For full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (<10th percentile for weight) at birth. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specific Aim 1 - Optimize VAA method for quantitative. The goal is to optimize the VAA system for small size of preterm tibia bone. | Obtaining a pediatric ultrasound transducer with smaller footprint and shallower focus is the first step for optimization. Secondly, using smallest size hydrophone with a high receiver sensitivity complete the optimization. The investigators will consider hydrophone bandwidth as a measure for optimal sensitivity. | 1 year. | |
Secondary | Specific Aim 2: Determine the efficacy of the VAA method for quantitative assessment of tibia bone in a pilot study of term and preterm infants. The goal is to measure the bone health of preterm newborn using our new ultrasound method. | Vibro-acoustic measurements for the age-adjusted premature infants will be compared to those of normal infants. Performance of vibro-acoustic in monitoring the treatment will be assessed by comparing to the measurement of previous visits. | through the study completion, up to 3 years |
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 | |
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 |
NCT05457036 -
Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile
|
N/A | |
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 |