Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT03463850
Eligibility Criteria:
Inclusion Criteria:
* Age 60 or greater Caucasian female with confirmed osteoporosis via prior DEXA.
* Patients with known vertebral fractures (Genant Grade 2 or higher) and with no fractures (Genant Score \<2) from prior DEXA/VFA analysis will be recruited.
* Patients with fractures must have at least one lumbar vertebral body with no fracture(s) (as seen on prior DEXA scan) for analysis.
Exclusion Criteria:
* Incidental finding to include pathology unrelated to osteoporosis that would directly affect bone architecture in the L spine (e.g. lytic bone lesions)
* Study DEXA scan reveals all lumbar vertebra have fractures (Genant \>= 2)
* Orthopedic hardware in the lumbar spine region
* Unable to have a CT scan (e.g. too heavy for CT scan table, 660 lb. limit)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT03463850
Study Brief:
Protocol Section:
NCT03463850