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 supplementatio
- Conditions
- distal radius fracturewrist fracture1001329610017322
- Registration Number
- NL-OMON41489
- Lead Sponsor
- Viecuri Medisch Centrum voor Noord-Limburg
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the changes in cortical and trabecular bone<br /><br>parameters that will be assessed by HR-pQCT and the changes in estimated bone<br /><br>strength and stiffness as calculated in the µFEA.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are the standard clinical and functional<br /><br>outcomes that are obtained using the PRWE and QuickDASH questionnaires, the<br /><br>pain score using VAS and the range of motion assessment. Furthermore, blood<br /><br>serum markers for bone formation and resorption will be measured.</p><br>