Distal Radius FracturesPhase 1/2NCT01859468
A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures
A Phase 1/2 study testing Amorphous calcium carbonate in people with Distal Radius Fractures, run by Amorphical Ltd. at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Amorphous calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2013to Feb 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bazilai Medical Center
Ashkelon, 78278
Barzilai Medical Center
Ashkelon
About this study
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
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.
Read more
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
Read the detailed description
Eligible subjects will be treated as follows:
Fifty (50) subjects will be randomly assigned to one of two groups (N=25). Subjects in the treatment group will receive amorphous calcium carbonate (ACC) and those in the active control group will receive placebo. Both formulations will be supplemented with vitamin D.
Safety parameters will be evaluated throughout the trial.
Subjects admitting to Barzilai medical center hand clinic following a new distal radius fracture will be routinely evaluated. Subjects who were initially treated according to current practice of fracture management, (i.e.; radiographic evaluation and fracture fixation by splint in plaster of Paris), who are not candidates for surgery and who are aimed for non-invasive treatment, will be considered candidates for the trial and be invited to the clinical research center (CRC) for screening.
Screening (Day -7) - Subjects will sign an informed consent form (ICF). Chemistry and hematology tests will be performed: sodium, potassium, hemoglobin, sedimentation rate, leukocytes calcium (total, albumin-corrected), phosphate, alkaline phosphatase, creatinine, and albumin. Also, serum parathyroid hormone (PTH), 25-hydroxyvitamin D, and thyroid-stimulating hormone (TSH) will be tested. Urinary excretion of calcium and creatinine will be measured. General health will be examined by medical history and physical examinations. Eligible subjects, complying with all inclusion criteria and none of the exclusion criteria will be enrolled to the study.
Subjects will be informed by phone or on site whether they are eligible to enter the study.
Visit 1 - 1 week from fracture - (Day 0 (-7/+1)) - Eligible subjects will be invited to the CRC. A fixture device will be applied to the cast to ensure consistence imaging. X-ray will be performed to exclude loss of reduction. Subjects will randomly receive packs of tablets (a total of 180 tablets, 42 day supply + 12 spare tablets), either tablets containing 200 mg elemental calcium from ACC or placebo (300 mg StarLac (starch cellulose and lactose blend)). Subjects who will arrive prior to day 0 will be instructed to begin the treatment exactly 7 days from the fracture event. Subjects will be instructed to take 4 tablets a day for the first 6 weeks (days 0-42), 2 tablets in the morning and 2 tablets in the evening, after a meal (i.e., the study group will consume a total of 800mg elemental calcium per day). To minimize the risks for calcium related side effects, subjects who take calcium regularly, will be instructed to discontinue their calcium supplements intake throughout the trial.
Visit 2 - 4 weeks from fracture - (Day 21±1) - Pre-dose serum calcium concentrations will be measured. The cast will be removed and controlled entero posterior and lateral x-ray will be taken. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. The wrist will be fixed using an adjustable brace. Subjects will be asked about any side effects or adverse events (AEs) that may have occurred. Subjects will complete the TSQM questionnaire with the representative of the CRC.
Visit 3 - 7 weeks from fracture - (Day 42±1) - Pre-dose serum calcium concentration and urinary calcium and creatinine concentrations will be measured. Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will receive additional packs of capsules, (a total of 180 capsules, 42 day supply + 12 spare capsules) with the same formulation received in day 0: either tablets containing 200 mg elemental calcium from ACC or placebo (300 mg StarLac (starch cellulose and lactose blend)). Subjects will be instructed to take 4 tablets a day for the next 6 weeks (days 42-84) 2 tablets in the morning and 2 tablets in the evening, after a meal (i.e., the study group will consume a total of 800mg elemental calcium per day). To minimize the risks for calcium related side effects, subjects who take calcium regularly, will be instructed to discontinue their calcium supplements intake throughout the trial. Subjects who did not show radiographic healing in the x-ray will be invited for an additional radiographic assessment on day 56.
Visit 4 - 9 weeks from fracture - (Day 56±1)* - Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred. Subjects that did not show radiographic healing in the x-ray will be invited for an additional radiographic assessment on day 70.
Visit 5 - 11 weeks from fracture - (Day 70±1)* - Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred.
Visit 6 - 13 weeks from fracture - (Day 84±1) - Pre-dose serum calcium and 25-hydroxyvitamin D concentration and urinary calcium and creatinine concentrations will be measured. Controlled entero posterior and lateral x-ray will be taken. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred. Subjects will complete the TSQM questionnaire with the representative of the CRC. The subjects will be instructed to discontinue the study treatment administration. Subjects that discontinued their regularly calcium supplementation at the beginning of the study will be instructed to continue their regular dose intake.
Visit 7 - 24 weeks from fracture - (Day 161±1) - Serum calcium concentration and urinary calcium and creatinine concentrations will be measured. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred.
- Only for subjects that did not show radiographic healing on x-ray performed on previous visit.
- Conditions
- Distal Radius Fractures
- Being tested
- Amorphous calcium carbonate, Placebo
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amorphous calcium carbonateDietary supplement
Also called ACC
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Amorphous calcium carbonate | Experimental | 200 mg elemental calcium tablets, 2 in the morning and 2 in the evening, after a meal Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omri Lubovsky, MD, Principal investigator, Barzilai Medical CenterEinat Dekel, DVM, Study director, Amorphical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859468
- Sponsor's protocol ID
- AMCS010
- Status last verified
- Mar 2015
- First submitted
- 19 May 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01859468
- Acronym / sponsor ID
- AMCS010
- Conditions
- Distal Radius Fractures
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Eligible subjects will be treated as follows:
Fifty (50) subjects will be randomly assigned to one of two groups (N=25). Subjects in the treatment group will receive amorphous calcium carbonate (ACC) and those in the active control group will receive placebo. Both formulations will be supplemented with vitamin D.
Safety parameters will be evaluated throughout the trial.
Subjects admitting to Barzilai medical center hand clinic following a new distal radius fracture will be routinely evaluated. Subjects who were initially treated according to current practice of fracture management, (i.e.; radiographic evaluation and fracture fixation by splint in plaster of Paris), who are not candidates for surgery and who are aimed for non-invasive treatment, will be considered candidates for the trial and be invited to the clinical research center (CRC) for screening.
Screening (Day -7) - Subjects will sign an informed consent form (ICF). Chemistry and hematology tests will be performed: sodium, potassium, hemoglobin, sedimentation rate, leukocytes calcium (total, albumin-corrected), phosphate, alkaline phosphatase, creatinine, and albumin. Also, serum parathyroid hormone (PTH), 25-hydroxyvitamin D, and thyroid-stimulating hormone (TSH) will be tested. Urinary excretion of calcium and creatinine will be measured. General health will be examined by medical history and physical examinations. Eligible subjects, complying with all inclusion criteria and none of the exclusion criteria will be enrolled to the study.
Subjects will be informed by phone or on site whether they are eligible to enter the study.
Visit 1 - 1 week from fracture - (Day 0 (-7/+1)) - Eligible subjects will be invited to the CRC. A fixture device will be applied to the cast to ensure consistence imaging. X-ray will be performed to exclude loss of reduction. Subjects will randomly receive packs of tablets (a total of 180 tablets, 42 day supply + 12 spare tablets), either tablets containing 200 mg elemental calcium from ACC or placebo (300 mg StarLac (starch cellulose and lactose blend)). Subjects who will arrive prior to day 0 will be instructed to begin the treatment exactly 7 days from the fracture event. Subjects will be instructed to take 4 tablets a day for the first 6 weeks (days 0-42), 2 tablets in the morning and 2 tablets in the evening, after a meal (i.e., the study group will consume a total of 800mg elemental calcium per day). To minimize the risks for calcium related side effects, subjects who take calcium regularly, will be instructed to discontinue their calcium supplements intake throughout the trial.
Visit 2 - 4 weeks from fracture - (Day 21±1) - Pre-dose serum calcium concentrations will be measured. The cast will be removed and controlled entero posterior and lateral x-ray will be taken. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. The wrist will be fixed using an adjustable brace. Subjects will be asked about any side effects or adverse events (AEs) that may have occurred. Subjects will complete the TSQM questionnaire with the representative of the CRC.
Visit 3 - 7 weeks from fracture - (Day 42±1) - Pre-dose serum calcium concentration and urinary calcium and creatinine concentrations will be measured. Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will receive additional packs of capsules, (a total of 180 capsules, 42 day supply + 12 spare capsules) with the same formulation received in day 0: either tablets containing 200 mg elemental calcium from ACC or placebo (300 mg StarLac (starch cellulose and lactose blend)). Subjects will be instructed to take 4 tablets a day for the next 6 weeks (days 42-84) 2 tablets in the morning and 2 tablets in the evening, after a meal (i.e., the study group will consume a total of 800mg elemental calcium per day). To minimize the risks for calcium related side effects, subjects who take calcium regularly, will be instructed to discontinue their calcium supplements intake throughout the trial. Subjects who did not show radiographic healing in the x-ray will be invited for an additional radiographic assessment on day 56.
Visit 4 - 9 weeks from fracture - (Day 56±1)* - Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred. Subjects that did not show radiographic healing in the x-ray will be invited for an additional radiographic assessment on day 70.
Visit 5 - 11 weeks from fracture - (Day 70±1)* - Controlled entero posterior and lateral x-ray will be taken without the brace. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred.
Visit 6 - 13 weeks from fracture - (Day 84±1) - Pre-dose serum calcium and 25-hydroxyvitamin D concentration and urinary calcium and creatinine concentrations will be measured. Controlled entero posterior and lateral x-ray will be taken. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred. Subjects will complete the TSQM questionnaire with the representative of the CRC. The subjects will be instructed to discontinue the study treatment administration. Subjects that discontinued their regularly calcium supplementation at the beginning of the study will be instructed to continue their regular dose intake.
Visit 7 - 24 weeks from fracture - (Day 161±1) - Serum calcium concentration and urinary calcium and creatinine concentrations will be measured. Functional assessment (pain-free grip and force plate) measurement and questionnaires (VAS, DASH) will be performed. Subjects will be asked about any side effects or AEs that may have occurred.
- Only for subjects that did not show radiographic healing on x-ray performed on previous visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amorphous calcium carbonate | Experimental | Dietary Supplement: Amorphous calcium carbonate200 mg elemental calcium tablets, 2 in the morning and 2 in the evening, after a meal |
| StarLac | Placebo comparator | Other: PlaceboTablets 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amorphous calcium carbonateAlso: ACC | Dietary supplement | Amorphous calcium carbonate |
| Placebo | Other | StarLac |
Primary outcome
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.
4 secondary outcomes
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)
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 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.
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)
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omri Lubovsky, MD principal investigator
Barzilai Medical Center
Einat Dekel, DVM study director
Amorphical Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amorphous calcium carbonate in people with Distal Radius Fractures, run by Amorphical Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.