The STRONGER study (Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability)
Purpose
The goal is to determine if CBMT, a new bone technology, detects differences in bone density among post-menopausal women who have recently experienced a fragility fracture (i.e., an arm or leg fracture, including a hip fracture, caused by falls from a height <6 inches) and women without a fracture history. Compensation up to $100 for participating.
Procedures
- All participants will undergo OsteoDx’s CBMT testing to assess bone stiffness
- Comparative dual-energy x-ray absorptiometry scans to assess bone mineral density.
- The total time to complete the study is expected to be less than 3 hours. The number of visits to complete testing will be 1-2.
Eligibility Criteria
Inclusion criteria for participants with fracture history
- Female
- Between the ages of 55-80
- Self-report that their last menses occurred at least 24-months prior to enrollment
- Objectively measured body mass index between 18.5 and 35 kg/m2 (i.e., healthy, overweight, or obese body weights)
- Experienced a fragility fracture after the age of 55 years. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture will not count if it is associated with 1) running, bicycling or other similar fast-moving activity such as sports subjects, 2) being struck by a falling or otherwise quickly moving heavy object, or 3) a motor vehicle accident
- Able to provide informed consent
Inclusion criteria for participants without fracture history
- Female
- Between the ages of 55-80
- Self-report that their last menses occurred at least 24-months prior to enrollment
- Objectively measured body mass index between 18.5 and 35 kg/m2 (i.e., healthy, overweight, or obese body weights)
- Self-reports not experiencing a fracture at any site after the age of 40 years (does not include fractures of the digits, toes or face).
- Does not self-report losing more than 1.5 inches in stature (height) in the previous 15 years.
- Able to provide informed consent
Exclusion criteria for all participants (those with and without fracture history)
- Failure to provide informed consent
- Living in a nursing home (those living in assisted living or independent housing will NOT be excluded).
- Self-reported type 1 diabetes.
- Unable to communicate because of severe hearing loss or speech disorder.
- Self-reports being told by a physician that they have a terminal illness.
- Self-reports current or recent pain or surgery (within 3-years) associated with the shoulder, wrist, or elbow joints (e.g., joint replacement, rotator cuff tear, severe osteoarthritis, etc.).
- Use of systemic glucocorticoids for more than 6-months in the prior one year.
- Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Pagets disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (stage 4+ chronic kidney disease, history of dialysis, kidney transplant, etc.) or hepatic insufficiency, prolonged immobilization (more than 2 months in the previous year).
To participate or if you have questions, please contact:
- Amal Alchbli via email aalchbli@ufl.edu or phone (352) 273-5916
Study Information Flyer
Gender
Female
Monetary compensation
Yes
Can be done from home
No
Keywords
Women's health , Osteoporosis, Bone mineral density test, Bone fracture repairPrincipal Investigator
Dr. Todd ManiniDepartment
Health Outcomes and Biomedical informatics
Contact Information
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