The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg
Würzburg, Bavaria, Germany
Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
Würzburg, Bavaria, Germany
Reduction of the Edema Area
The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening
Time frame: Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)
Reduction of Pain (VAS)
Reduction of pain as measured by a Visual Analog Scale (VAS). Range 0-100 with higher values indicating worse pain.
Time frame: Assessment at week 3
Reduction of Pain
Reduction of pain as measured by a visual analog scale (VAS). Range 0-100. Higher values indicating worse pain.
Time frame: Assessment at week 6
Quality of Life (Qualeffo-41 Questionnaire)
Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with fractures of the European Foundation for Osteoporosis Higher values indicate worse quality of life
Time frame: Assessment at week 3
Quality of Life (Qualeffo-41 Questionnaire)
Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with vertebral fractures of the European Foundation for Osteoporosis
Time frame: Assessment at week 6
Subjective Estimation of Medical Condition (PDI)
Subjective estimation of medical condition as assessed by PDI (Pain Disability Index). Range 0-70. The higher the index the greater the person's disability due to pain.
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Time frame: Assessment at week 3
Subjective Estimation of Medical Condition (PDI)
Subjective estimation of medical condition as assessed by PDI (Pain Disability Index)
Time frame: Assessment at week 6
Number of Additional Medicinal Visits
Number of additional medicinal visits until week 3
Time frame: Assessment at week 3
Number of Additional Medicinal Visits
Aggregated number of unscheduled medicinal visits
Time frame: Assessment at week 6
Number of Days of Illness
Aggregated number of days of illness i.e. sick leave from work, assessed until week 6
Time frame: Assessment at week 6
Number of Days of Illness
Number of days of illness assessed until week 6
Time frame: Assessment at week 6
Number of Aseptic Bone Necrosis and Fatigue Fractures
Assessment of number of patients withaseptic bone necrosis and/or fatigue fractures.
Time frame: Baseline until end of study (week 12)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP
Time frame: Week 3, 6