Status:
UNKNOWN
Radio-frequency Identification (RFID) Osteoporosis Pilot Study
Lead Sponsor:
Neva Electromagnetics, LLC
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Age-Related Bone Loss
Bone Loss, Age Related
Eligibility:
FEMALE
27-80 years
Brief Summary
This examines in-vivo microwave sensing to measure a radio- frequency signal propagating through the wrist and, based on this information, establish a correlation of measured parameters with the integ...
Eligibility Criteria
Inclusion
- In osteoporotic patients:
- 50-80 years of age
- Established diagnosis of osteoporosis, based on prior dual energy x-ray absorptiometry (DXA) scan with T-score \<-2.0 at any site and/or history of fragility fracture
- In healthy controls:
- 27-40 years of age
- Female
Exclusion
- In osteoporotic patients:
- Current or recent (within 2 years) use of osteoporosis medications including bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, teriparatide, denosumab, calcitonin, or strontium
- Pregnancy or breastfeeding within the past 2 years
- Any medical or psychiatric condition or situation that would compromise subject safety, informed consent/assent, or data quality
- In healthy controls:
- History of significant cardiac, renal, pulmonary, hepatic, or malignant disease, or current alcohol or illicit drug abuse
- Current diagnoses known to effect bone metabolism, including cystic fibrosis, diabetes, osteoporosis, amenorrhea \>3 months (in menstruating women who are not taking oral contraceptives or have an IUD), hyperthyroidism, hyperparathyroidism, Paget's disease, kidney stones, chronic inflammatory diseases, malabsorptive disorders, malnutrition or eating disorder, endocrine disorders (growth disorder, Cushing syndrome), prolonged immobility, and skeletal dysplasias
- History one or more pathologic fracture, or greater than four total lifetime non-digital, non-facial fractures
- Cumulative lifetime use of oral glucocorticoids for greater than 2 months
- Current or previous use of medications known to affect bone metabolism including hormone replacement therapy, anti-estrogens, bisphosphonates, calcitonin, lithium, suppressive doses of levothyroxine, or anticonvulsants.
- Pregnancy or breastfeeding within the past 2 years
- BMI less than 18.5 or greater than 30 kg/m2.
- Any medical or psychiatric condition or situation that would compromise subject safety, informed consent/assent, or data quality
Key Trial Info
Start Date :
January 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03385941
Start Date
January 31 2018
End Date
December 1 2018
Last Update
January 26 2018
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