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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Change from baseline in radiographic fracture healing
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change from baseline in radiographic fracture healing
时间窗: 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.
次要结局
- 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))
- 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))
- 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))