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A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures

Amorphical Ltd. · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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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 fracture healing process. The active mineralization can most probably be attributed to the mineral component of this substance. The distal radius fracture was chosen as the model to test the effects of ACC treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints. Primary objective: To assess the efficacy of treatment with calcium from ACC compared to placebo on radiographic healing time in subjects with distal radius fractures. Secondary objectives: * To evaluate the effect of ACC compared to placebo on the improvement in wrist functional outcome following distal radius fracture. * To evaluate the safety profile of ACC in this population
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