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Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome

NCT01348269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-08-13

Study results available
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Summary

The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.

Conditions

  • Bone Marrow Edema

Interventions

DRUG

Aclasta

1 x intravenous non-current drip (infusion)

DRUG

Placebo

NaCl Solution

Sponsors & Collaborators

  • Crolll Gmbh

    collaborator OTHER

  • University of Wuerzburg

    collaborator OTHER

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Rainer Meffert, Prof. Dr. · Department of trauma, hand, reconstructive and plastic, University of Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-08-26
Completion
2015-08-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348269 on ClinicalTrials.gov