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

NCT01859468 | Terminated Phase 1

• 1 other identifier: AMCS010
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in radiographic fracture healing

  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.

  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)

Secondary Outcomes (4)

• Change from baseline in improvement of function

  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)

• Change from baseline in reduction of symptoms and signs related to distal radius fractures

  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 calcium side effects

  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.

• Change from baseline in fracture gap and callus calcification

  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)

Study Arms (2)

Amorphous calcium carbonate

EXPERIMENTAL

200 mg elemental calcium tablets, 2 in the morning and 2 in the evening, after a meal

Dietary Supplement: Amorphous calcium carbonate

StarLac

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Amorphous calcium carbonate DIETARY_SUPPLEMENT

Also known as: ACC

Amorphous calcium carbonate

Placebo OTHER

StarLac

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Amorphical Ltd.: lead

Study Sites (2)

Bazilai Medical Center

Ashkelon, 78278, Israel

Location

Barzilai Medical Center

Ashkelon, Israel

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Omri Lubovsky, MD

  Barzilai Medical Center

  PRINCIPAL INVESTIGATOR

• Einat Dekel, DVM

  Amorphical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 22, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2015-03

Locations

IL (2)