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

NCT01859468 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-08-04

No results posted yet for this study

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 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

Conditions

  • Distal Radius Fractures

Interventions

DIETARY_SUPPLEMENT

Amorphous calcium carbonate

OTHER

Placebo

Sponsors & Collaborators

  • Amorphical Ltd.

    lead INDUSTRY

Principal Investigators

  • Omri Lubovsky, MD · Barzilai Medical Center

  • Einat Dekel, DVM · Amorphical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859468 on ClinicalTrials.gov