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: 

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 repair

Principal Investigator

Dr. Todd Manini

Department

Health Outcomes and Biomedical informatics

Contact Information

aalchbli@ufl.edu

(352) 273-5916


Be an Informed Participant

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