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| ID | Type | Description | Link |
|---|---|---|---|
| Bone marrow edema | Other Identifier | Medical Uiversity Vienna - Vinforce |
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no patients randomized
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Active Comparator | daily subcutaneous injection of teriparatide 20µg for three months |
|
| Placebo Teriparatide | Placebo Comparator | daily subcutaneous teriparatide placebo injection |
|
| Denosumab | Active Comparator | one subcutaneous injection of denosumab |
|
| Placebo Denosumab | Active Comparator | one subcutaneous injection of denosumab placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | sc RANKL-inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs | MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score | baseline - month 1 - month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Muschitz, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna - St. Vincent Hospital | Vienna | State of Vienna | 1060 | Austria |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D019379 | Teriparatide |
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Teriparatide |
| Drug |
daily subcutaneous injection of teriparatide |
|
|
| Placebo Denosumab | Drug | one subcutaneous injection denosumab placebo |
|
|
| Placebo Teriparatide | Drug | daily subcutaneous placebo injection |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |