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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Amorphical Ltd.
Sponsor:
Information provided by (Responsible Party):
Amorphical Ltd.
ClinicalTrials.gov Identifier:
NCT01859468
First received: May 19, 2013
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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

Condition Intervention Phase
Distal Radius Fractures
Dietary Supplement: Amorphous calcium carbonate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Amorphical Ltd.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: Yes ]

    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) ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859468

Contacts
Contact: Michal Daniely, PhD 97286479316 michald@amorphical.com

Locations
Israel
Bazilai Medical Center Not yet recruiting
Ashkelon, Israel, 78278
Contact: Ora Ushkats    +97286745535    orau@barzi.health.gov.il   
Contact: Omri Lubovsky, MD    +972505172435    omrilu@gmail.com   
Principal Investigator: Omri Lubovsky, MD         
Sub-Investigator: Ronen Debbi, MD         
Sub-Investigator: Hagar Patish, MD         
Sub-Investigator: Dan Debbi, MD         
Sponsors and Collaborators
Amorphical Ltd.
Investigators
Principal Investigator: Omri Lubovsky, MD Barzilai Medical Center
Study Director: Michal Daniely, PhD Amorphical Ltd.
  More Information

No publications provided

Responsible Party: Amorphical Ltd.
ClinicalTrials.gov Identifier: NCT01859468     History of Changes
Other Study ID Numbers: AMCS010
Study First Received: May 19, 2013
Last Updated: May 21, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Carbonate
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014