NL-OMON41489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 supplementation - Fracture healing assessed by HRpQCT in standard care and after calcium
Viecuri Medisch Centrum voor Noord-Limburg0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
- •2. Patients with a stable distal radius fracture type that is treated by cast immobilization.
- •3. 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.
- •4. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
排除标准
- •1. Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
- •2. Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
- •3. Patients with malignancy or a pathological fracture in the last 12 months.
- •4. 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.
- •5. 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
- •6. 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.
- •7. The use of glucocorticoids during the last 12 months.
- •8. 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.
- •9. Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
- •10. Patients with other severe concurrent joint involvements that can affect their outcome.
- •11. Patients who are already selected for another trial concerning distal radius fractures.
研究者
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