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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT03076034
Eligibility Criteria:
Inclusion Criteria:
* Women with hip and wrist fractures within 2 weeks of presentation
* Non-fracture controls
Exclusion Criteria:
* Unable to undergo BMD by DXA or high-resolution peripheral quantitative computed tomography (HR-pQCT)
* History of skeletal metastasis, primary hyperparathyroidism, Paget's disease, multiple myeloma
* Treatment with bisphosphonate, estrogen (within previous 3 years), teriparatide therapy, calcitonin, selective estrogen receptor modulator (SERMs,within previous 3 years)
* Use of glucocorticoids continuously for more than 3 months, use of anticonvulsants
* Prior fracture in adulthood (\>age 18) for healthy controls
Amendment to protocol added Arm 2, to include males \>50 years with otherwise similar eligibility criteria.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
100 Years
Study:
NCT03076034
Study Brief:
Protocol Section:
NCT03076034