Assessment of fracture healing by high-resolution peripheral quantitative computer tomography (HRpQCT) and bone strength analysis in standard care and after immediate administration of vitamin D.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

1.Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma. 2.2. Patients with any non-operative stable distal radius fracture 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. 4.Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion Criteria

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 in the last 12 months. 4.The patient with a neuromuscular or neurosensory deficit 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: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR<30 ml/min 6.Patients with an active inflammatory disease during the last year such as reumatoid arthritis, SLE, inflammatory bowel disease (M. Crohn and colitis ulcerosa) 7.The prolonged use of oral glucocorticoids during the last 6 months 8.Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule. 9.Patients with other severe concurrent joint involvements which can affect their outcome. 10.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>Fracture healing group:<br /><br>The primary objective is to study healing of distal radius fractures in<br /><br>postmenopausal women in terms of alterations in micro-architecture and<br /><br>calculated bone strength based on the results of cortical and trabecular bone<br /><br>parameters in the first 12 weeks after fracture, using a novel high resolution<br /><br>peripheral quantitative computer tomography (HRpQCT) device. Using this<br /><br>technique we will develop a computer based model for fracture healing<br /><br><br /><br>Intervention group:<br /><br>Primary outcome: to compare the effect of immediate administration of two<br /><br>dosages of vitamin D (800 and 2000 IU/day) vs. standard care (administration of<br /><br>vitamin D more than 12 weeks after fracture) on fracture healing and functional<br /><br>outcome.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Intervention group:<br /><br>Secondary outcome: to compare the healing of distal radius fractures in terms<br /><br>of calculated bone strength based on the results of cortical and trabecular<br /><br>bone parameters using HRpQCT (XtremeCT device, Scanco, Switzerland) using the<br /><br>developed computer based model, between immediate vitamin D supplementation<br /><br>(800 and 2000 IU/day) and standard care.</p><br>