Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
This study is currently recruiting participants.
Verified November 2012 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Dr. Christian Muschitz, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01734824
First received: June 2, 2012
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Marrow Oedema Syndrome High Turnover Bone Disease Quality of Life |
Drug: Denosumab Drug: Teriparatide Drug: Placebo Denosumab Drug: Placebo Teriparatide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo |
Resource links provided by NLM:
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs [ Time Frame: baseline - month 1 - month 3 ] [ Designated as safety issue: Yes ]MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Teriparatide
daily subcutaneous injection of teriparatide 20µg for three months
|
Drug: Teriparatide
daily subcutaneous injection of teriparatide
Other Name: PTH 1-34
|
|
Placebo Comparator: Placebo Teriparatide
daily subcutaneous teriparatide placebo injection
|
Drug: Placebo Teriparatide
daily subcutaneous placebo injection
Other Name: PTH 1-34
|
|
Active Comparator: Denosumab
one subcutaneous injection of denosumab
|
Drug: Denosumab
sc RANKL-inhibitor
Other Name: Prolia
|
|
Active Comparator: Placebo Denosumab
one subcutaneous injection of denosumab placebo
|
Drug: Placebo Denosumab
one subcutaneous injection denosumab placebo
Other Name: Prolia
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734824
Contacts
| Contact: Christian Muschitz, MD | +43159988 ext 2119 | christian.muschitz@bhs.at |
| Contact: Afrodite Zendeli, MD | +43159988 ext 6050 | afrodite.zendeli@bhs.at |
Locations
| Austria | |
| Medical University Vienna - St. Vincent Hospital | Recruiting |
| Vienna, Austria, 1060 | |
| Contact: Christian Muschitz, MD +43159988 ext 2119 christian.muschitz@bha.at | |
| Contact: Afrodite Zendeli, MD +43159988 ext 6050 afrodite.zendeli@bhs.at | |
| Principal Investigator: Christian Muschitz, MD | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| Principal Investigator: | Christian Muschitz, MD | Medical University of Vienna |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Christian Muschitz, Principal Investigator, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01734824 History of Changes |
| Other Study ID Numbers: | Vinforce-012, Bone marrow edema |
| Study First Received: | June 2, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
bone marrow edema, denosumab, PTH 1-84 |
Additional relevant MeSH terms:
|
Bone Diseases Edema Musculoskeletal Diseases Signs and Symptoms |
Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013