- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734824
Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1060
- Medical University Vienna - St. Vincent Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Teriparatide
daily subcutaneous injection of teriparatide 20µg for three months
|
daily subcutaneous injection of teriparatide
Other Names:
|
Placebo Comparator: Placebo Teriparatide
daily subcutaneous teriparatide placebo injection
|
daily subcutaneous placebo injection
Other Names:
|
Active Comparator: Denosumab
one subcutaneous injection of denosumab
|
sc RANKL-inhibitor
Other Names:
|
Active Comparator: Placebo Denosumab
one subcutaneous injection of denosumab placebo
|
one subcutaneous injection denosumab placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
Time Frame: baseline - month 1 - month 3
|
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
|
baseline - month 1 - month 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Muschitz, MD, Medical University of Vienna
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vinforce-012
- Bone marrow edema (Other Identifier: Medical Uiversity Vienna - Vinforce)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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