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Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01734824
Recruitment Status : Suspended (no patients randomized)
First Posted : November 28, 2012
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment Phase
Bone Marrow Oedema Syndrome High Turnover Bone Disease Quality of Life Drug: Denosumab Drug: Teriparatide Drug: Placebo Denosumab Drug: Placebo Teriparatide Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
Study Start Date : May 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734824


Locations
Austria
Medical University Vienna - St. Vincent Hospital
Vienna, Austria, 1060
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Muschitz, MD Medical University of Vienna
More Information

Additional Information:
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 ( Other Identifier: Medical Uiversity Vienna - Vinforce )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Dr. Christian Muschitz, Medical University of Vienna:
bone marrow edema, denosumab, PTH 1-84

Additional relevant MeSH terms:
Edema
Bone Diseases
Signs and Symptoms
Musculoskeletal Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs