- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01348269
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome (ZoMARS)
June 7, 2017 updated by: Dr. Lothar Seefried, Wuerzburg University Hospital
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 3
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
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Bavaria
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Wuerzburg, Bavaria, Germany, 97074
- Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg
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Wuerzburg, Bavaria, Germany, 97080
- Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:
- ≥ 12 month persistent natural (spontaneous) amenorrhoea (women aged <50: additionally: FSH >40MIE/ml and estrogen deficiency of <30pg/ml or a negative estrogen test)
- status post hysterectomy and / or bilateral oophorectomy
- finished reproduction planning
- secure diagnosis of bone marrow edema using MRT
- current osteologic basic laboratory values (≤ 4 weeks before V2) according to DVO criteria
- presence of an personally signed informed consent for the participation in the study
Exclusion Criteria:
- - subchondral bone loss or already occurred cartilage damage due to the bone marrow edema
- reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)
- patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)
- patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis
- patients with bone necrosis in the painful skeletal region
- patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively
- patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides
patients with advanced renal insufficiency (GFR according to Cockcroft
/ Gault ≤ 40 ml/min/KO)
- patients with malignant diseases with osseous manifestation in anamnesis/history
- status post malignant basic/primary disease with large dosed chemotherapy
- current or massive dose therapy completed before less than 6 weeks (>7.5mg prednisolon equivalent) with glucocorticoids
- patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis
- vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia
- etiological vague/ambiguous AP-increase
- symptomatic renal calculus or nephrocalcinosis within 2 years before V2
- recent fracture within the last 3 months independent of the localisation
- non consolidated fractures
- previous treatment with i.v. bisphosphonates within the last 12 months
- previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months
- pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months
- Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment
- pregnancy or nursing period
- patients immediately involved in the conduction of the trial and relatives
- patients with current proceedings related to the bone marrow edema
- patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator
- participation in another clinical trial within 30 days before study start or during the trial
- participation of patient who might be dependent on the investigator, also the spouse, parents or children
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: NaCl Solution
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NaCl Solution
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Active Comparator: Aclasta
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1 x intravenous non-current drip (infusion)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of the Edema area
Time Frame: Week 6 after study start
|
Week 6 after study start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of pain (VAS)
Time Frame: Week 0, 3, 6
|
Week 0, 3, 6
|
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Quality of life (Qualeffo-41 questionnaire - Quality of life questionnaire of the European Foundation for Osteoporosis)
Time Frame: Week 0, 3, 6
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Week 0, 3, 6
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Subjective estimation of medical condition (PDI)
Time Frame: Week 0, 3, 6
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Week 0, 3, 6
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|
Number of additional medicinal visits
Time Frame: Week 3, 6
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Week 3, 6
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Number of days of illness
Time Frame: Week 3, 6
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Week 3, 6
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Week 3, 6
|
including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP
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Week 3, 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Rainer Meffert, Prof. Dr., Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
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 (Actual)
May 1, 2011
Primary Completion (Actual)
August 26, 2015
Study Completion (Actual)
August 26, 2015
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 4, 2011
First Posted (Estimate)
May 5, 2011
Study Record Updates
Last Update Posted (Actual)
June 8, 2017
Last Update Submitted That Met QC Criteria
June 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZOL446HDE38T
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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