A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures
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.
To assess the efficacy of treatment with calcium from ACC compared to placebo on radiographic healing time in subjects with distal radius fractures.
- 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
|Distal Radius Fractures||Dietary Supplement: Amorphous calcium carbonate Other: Placebo||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Parallel, Double-blind, Active Controlled Pilot Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) Versus Placebo on Functional Outcome and Radiographic Healing Time of Distal Radius Fractures|
- Change from baseline in radiographic fracture healing [ Time Frame: Radiographic images (X-ray) will be performed for each subject from day 0 and onward: Day 21, 42, 56*, 70*, 84 (* Only for subjects that did not show radiographic healing on x-ray performed on day 42) ]Radiographic healing will be defined as the interval in days between the occurrence of the fracture and the time when bridging in three of four cortices is seen on X-ray images. A determination will be made at each follow up evaluation for the two cortices (radial and ulnar) visible on the anteroposterior X-ray film and the two (dorsal and volar) seen on the lateral film.
- Change from baseline in improvement of function [ Time Frame: Functional assessment will be performed at 3, 6, 8*, 10* and 12 weeks from treatment (*only for subjects that did not show radiographic healing on x-ray performed on previous visit) ]
Functional assessments will be performed as follows:
- Pain-free grip: assessment of grip strength via a JAMAR dynamometer. The dynamometer is linked to software that easily and accurately measures grip strength. The dynamometer measures in increments of 0.1 kg. The mean of the three measurements, 2 min apart, will be considered as the grip strength for a patient at a specific visit. To adjust for hand dominance in grip strength, if the non-dominant hand was injured, the percentage will be multiplied by 1.07; if the dominant hand was injured, the percentage will be multiplied by 0.93.
- Pain free weight bearing: assessment of hand weight bearing will be measured using FP2 force plate. The FP2 force plate is controlled by the amount of force applied and can be set in 0.1 kg increments. The force plate is very sensitive and responds to as little as the touch of a finger. The maximum force generated is measured by software connected to the force plate.
- Change from baseline in reduction of symptoms and signs related to distal radius fractures [ Time Frame: Measurments will be performed at 3, 6, 8*, 10* and 12 weeks from treatment (*only for patients who did not show radiographic healing on previous visit) ]
Assessment of symptoms and signs related to distal radius fractures will be performed using the following questionnaires:
- DASH score: a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.
- Pain evaluation by VAS questionnaires.
- Assessment of calcium side effects [ Time Frame: Serum calcium measurments will be performed at screening and at 3, 6, 12 and 23 weeks from treatment. TSQM questionnaire will be applied at 3 and 12 weeks from treatment. ]
Assessment of calcium side effects:
- Safety parameters: serum calcium tests
- Treatment satisfaction questionnaire for medication (TSQM): Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction for medication. The TSQM Version 1.4 is a 14-item psychometrically robust and validated instrument consisting of four scales. The four scales of the TSQM include the effectiveness scale (questions 1 to 3), the side effects scale (questions 4 to 8), the convenience scale (questions 9 to 11) and the global satisfaction scale (questions 12 to 14)
- Change from baseline in fracture gap and callus calcification [ Time Frame: Radiographic images (X-ray) will be performed for each subject in each CRC visit from day 0 and onward: Day 21, 42, 56*, 70*, 84 (* Only for subjects that did not show radiographic healing on x-ray performed on day 42) ]
Hard callus formation starts peripherally and progressively moves towards the center of the fracture and the fracture gap.
The formation of callus will be measured using digital image analysis tools. Region of interest (ROI) will be marked. For each ROI, measurements will be performed for cortex union and fracture gap and callus calcification. The pixel value ratio (PVR) approach will be used to demonstrate the healing progression. The PVR approach measures the serial changes in callus mineralization in different cortices of the callus to ascertain the callus stiffness in order to provide objective parameters for decision making.
|Study Start Date:||June 2013|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Amorphous calcium carbonate
200 mg elemental calcium tablets, 2 in the morning and 2 in the evening, after a meal
Dietary Supplement: Amorphous calcium carbonate
Other Name: ACC
Placebo Comparator: StarLac
Tablets containing 300 mg StarLac (starch cellulose and lactose blend) to be used as placebo, 2 tablets in the morning and 2 tablets in the evening, after a meal.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01859468
|Bazilai Medical Center|
|Ashkelon, Israel, 78278|
|Barzilai Medical Center|
|Principal Investigator:||Omri Lubovsky, MD||Barzilai Medical Center|
|Study Director:||Einat Dekel, DVM||Amorphical Ltd.|