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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01691833
Eligibility Criteria:
Inclusion Criteria:
* presence of a long bone fracture (humerus, femur, or tibia)
* age greater than or equal to 18 years
* ability to follow-up at our clinic for 12 months
Exclusion Criteria:
* pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor, cyst, or Paget's disease)
* open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C (i.e. significant soft-tissue and bone devitalization)
* presence of multiple fractures
* delay in presentation for initial treatment of more than 2 weeks from the time of injury
* preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
* preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
* pregnant patients
* patients who are unable to provide consent for the study
* patients who are unable to swallow due to acuity of illness or physiologic reason
* prisoners who are patients because of their vulnerable population and inability to follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01691833
Study Brief:
Protocol Section:
NCT01691833