A Phase 4 interventional study of Denosumab and Teriparatide in Bone Marrow Oedema Syndrome, High Turnover Bone Disease and Quality of Life, sponsored by Medical University of Vienna. Suspended at 1 site in Austria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
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
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.
261 studies on the registry are indexed under Bone Diseases; 49 are open to participants now.
This study's planned enrollment of 90 is above the median of 54 across 148 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
daily subcutaneous injection of teriparatide 20µg for three months
Drug: Teriparatide
daily subcutaneous teriparatide placebo injection
Drug: Placebo Teriparatide
one subcutaneous injection of denosumab
Drug: Denosumab
one subcutaneous injection of denosumab placebo
Drug: Placebo Denosumab
sc RANKL-inhibitor
Also known as: Prolia
daily subcutaneous injection of teriparatide
Also known as: PTH 1-34
one subcutaneous injection denosumab placebo
Also known as: Prolia
daily subcutaneous placebo injection
Also known as: PTH 1-34
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
Time frame: baseline - month 1 - month 3
This study is suspended, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna