Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life
Conditions
Keywords
bone marrow edema, denosumab, PTH 1-84
Brief summary
The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs. This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME
Detailed description
Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily teriparatide sc for three months or placebo. MRI examinations at baseline and after three months will be performed. Serum bone turnover markers will be evaluated as well as QoL questionnaires.
Interventions
DRUGDenosumab
sc RANKL-inhibitor
DRUGTeriparatide
daily subcutaneous injection of teriparatide
DRUGPlacebo Denosumab
one subcutaneous injection denosumab placebo
daily subcutaneous placebo injection
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* MRI diagnosed bone marrow edema
Exclusion criteria
* any prior antiresorptive or osteoanabolic treatment * any prior therapy with strontium ranelate * Hyper-/hypocalcemia * malignancies * pregnancy * and contraindication against denosumab or teriparatide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs | baseline - month 1 - month 3 | MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score |
Countries
Austria
Outcome results
None listed