NCT02889237已完成不适用
Assessment of Fracture Healing by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) and Bone Strength Analysis in Standard Care and After Immediate Administration of Calcium and Vitamin D Supplementation
VieCuri Medical Centre2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Bone strength
研究概览
简要总结
This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in terms of calculated bone strength based on analysis of cortical and trabecular bone parameters using HR-pQCT, fracture healing and functional outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
- •Patients with a stable distal radius fracture treated by cast immobilization.
- •Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations and the prescribed rehabilitation.
- •Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
排除标准
- •Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
- •Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
- •Patients with malignancy or a pathological fracture in the last 12 months.
- •Patients with a neuromuscular or neurosensory deficit, e.g. Parkinson's disease, which would limit the ability to assess the performance during the healing period.
- •Patients with known systemic or metabolic disorders leading to progressive bone deterioration, such as: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR<30 ml/min, sarcoidosis, hypercalcemia,
- •Patients with an active inflammatory disease during the last year such as rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis.
- •The use of glucocorticoids during the last 12 months.
- •Patients with an allergy to calcium, calcium carbonate, cholecalciferol, aspartame, citric-acid, lactose, dimethicone, methylcellulose, sorbic acid, macrogole, polyvidone, mannitol, orange flavour, natriumsaccharine, starch or sucrose.
- •Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
- •Patients with other severe concurrent joint involvements that can affect their outcome.
- •Patients who are already selected for another trial concerning distal radius fractures.
结局指标
主要结局
Bone strength
时间窗: 1 year
Bone strength parameters will be assessed by HRpQCT
次要结局
- Functional outcome assessed by PRWE(1 year)
- Functional outcome assessed using VAS for pain score(1 year)
- Functional outcome assessed by QuickDASH(1 year)
- Functional outcome assessed using range of motion(1 year)
- Fracture healing(1 year)
研究者
Joop P.W. van den Bergh
Prof. dr. J.P.W. van den Bergh, Endocrinologist
VieCuri Medical Centre
研究点 (2)
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