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

September 22, 2015 updated by: Dr. Christian Muschitz, Medical University of Vienna

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

Suspended

Conditions

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

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1060
        • Medical University Vienna - St. Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Teriparatide
daily subcutaneous injection of teriparatide
Other Names:
  • PTH 1-34
Placebo Comparator: Placebo Teriparatide
daily subcutaneous teriparatide placebo injection
Drug: Placebo Teriparatide
daily subcutaneous placebo injection
Other Names:
  • PTH 1-34
Active Comparator: Denosumab
one subcutaneous injection of denosumab
Drug: Denosumab
sc RANKL-inhibitor
Other Names:
  • Prolia
Active Comparator: Placebo Denosumab
one subcutaneous injection of denosumab placebo
Drug: Placebo Denosumab
one subcutaneous injection denosumab placebo
Other Names:
  • Prolia

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

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Muschitz, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

June 2, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

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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