Status:
TERMINATED
A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures
Lead Sponsor:
Amorphical Ltd.
Conditions:
Distal Radius Fractures
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
PHASE2
Brief Summary
Amorphical has a strong basis to believe that the Amorphous Calcium Carbonate (ACC) product has an effect on active mineralization during bone remodelling hence, it has a potential to accelerate fract...
Detailed Description
Eligible subjects will be treated as follows: Fifty (50) subjects will be randomly assigned to one of two groups (N=25). Subjects in the treatment group will receive amorphous calcium carbonate (ACC)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01859468
Start Date
June 1 2013
End Date
February 1 2015
Last Update
August 4 2016
Active Locations (2)
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1
Bazilai Medical Center
Ashkelon, Israel, 78278
2
Barzilai Medical Center
Ashkelon, Israel