distal radius fracture wrist fracture
Conditions
Interventions
30 postmenopausal women with a non-operative stable distal radius fracture to
compare the effect of immediate administration of vitamin D on fracture healing
with usual care (i.e. administration of
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing group: The primary objective is to study healing of distal radius fractures in postmenopausal women in terms of alterations in micro-architecture and calculated bone strength based on the results of cortical and trabecular bone parameters in the first 12 weeks after fracture, using a novel high resolution peripheral quantitative computer tomography (HRpQCT) device. Using this technique we will develop a computer based model for fracture healing Intervention group: Primary outcome: to compare the effect of immediate administration of two dosages of vitamin D (800 and 2000 IU/day) vs. standard care (administration of vitamin D more than 12 weeks after fracture) on fracture healing and functional outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intervention group: Secondary outcome: to compare the healing of distal radius fractures in terms of calculated bone strength based on the results of cortical and trabecular bone parameters using HRpQCT (XtremeCT device, Scanco, Switzerland) using the developed computer based model, between immediate vitamin D supplementation (800 and 2000 IU/day) and standard care. | — |
Countries
Netherlands
Outcome results
None listed