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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT01859468
Eligibility Criteria:
Inclusion Criteria:
* Subjects with closed unilateral dorsally angulated fracture of the distal radius (Colles') visible by x-ray.
* Subjects that can begin taking the study treatment exactly 7 (+1) days from the fracture event.
* Subjects treated conservatively by closed reduction and immobilization
* Age 50-90 (inclusive)
* Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Subject that had signed the ICF.
Exclusion Criteria:
* Subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation.
* Subjects with pins or plates in the wrist
* Sustained previous fractures or bone surgery in the currently fractured distal forearm
* Subjects with multiple trauma (several fractures at once)
* Subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm.
* Elevated serum calcium (\> 10.2 mg/dL)
* 25-hydroxyvitamin D \< 20 ng/mL
* Subjects suffering from active liver disease or clinical jaundice
* Subjects with current or a history of a malignant neoplasm in the 5 years prior to the study
* Cognitive impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01859468
Study Brief:
Protocol Section:
NCT01859468