Osteoporotic vertebral compression fractures (OVCFs)
Conditions
Interventions
This is a multicenter, two-armed, parallel-group randomized controlled trial with a 1:1 allocation ratio consisting of an effect, economic and process evaluation. Postmenopausal women with a recent sy
Sponsors
Bauerfeind
Eligibility
Inclusion criteria
Inclusion criteria: - Postmenopausal women; - A symptomatic thoracolumbar osteoporotic vertebral compression fracture (less than 6 weeks old); - Eligible for questionnaires with sufficient understanding of the Dutch written language.
Exclusion criteria
Exclusion criteria: - Unstable vertebral fractures amenable for operative treatment; - Neurologic deficit; - Severe spinal deformity (scoliosis); - Infection; - Active cancer; - Psychiatric or mental disease; - Insufficient cognitive or language skills to complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is quality of life at one year after intervention. This will be measured using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (Qualeffo-41). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. Static sagittal alignment and recurrence fracture rate will be analyzed on standardized lateral full-spine radiographs using validated software. For patients included in the Maastricht University Medical Center gait quality and postural balance will be assessed using the computer-assisted rehabilitation environment (CAREN, Motek-force Link). Physical activity and gait speed in daily life will be assessed with the MOX activity monitor. | — |
Contacts
Public ContactEva Jacobs
Maastricht University Medical Center
Outcome results
None listed