NCT01348269

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

A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Aclasta	1 x intravenous non-current drip (infusion)
DRUG	Placebo	NaCl Solution

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-08-26
• Completion: 2015-08-26
• First posted: 2011-05-05
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

2 sites across 1 country: Germany