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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Wuerzburg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Crolll Gmbh
University of Wuerzburg
Information provided by (Responsible Party):
Rainer Meffert, Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01348269
First received: May 2, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Bone Marrow Edema
Drug: Aclasta
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Reduction of the Edema area [ Time Frame: Week 6 after study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of pain (VAS) [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: No ]
  • Quality of life (Qualeffo-41 questionnaire - Quality of life questionnaire of the European Foundation for Osteoporosis) [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: No ]
  • Subjective estimation of medical condition (PDI) [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: No ]
  • Number of additional medicinal visits [ Time Frame: Week 3, 6 ] [ Designated as safety issue: No ]
  • Number of days of illness [ Time Frame: Week 3, 6 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Week 3, 6 ] [ Designated as safety issue: Yes ]
    including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP


Estimated Enrollment: 48
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aclasta Drug: Aclasta
1 x intravenous non-current drip (infusion)
Placebo Comparator: NaCl Solution Drug: Placebo
NaCl Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348269

Locations
Germany
Department of trauma, hand, reconstructive and plastic, University of Wuerzburg Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Rainer Meffert, Prof. Dr.    0049 931 201 ext 37001    meffert_r@klinik.uni-wuerzburg.de   
Principal Investigator: Rainer Meffert, Prof. Dr.         
Sub-Investigator: Timo Heintel, Dr. med.         
Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg Recruiting
Wuerzburg, Bavaria, Germany, 97074
Contact: Franz Jakob, Prof. Dr    0049 931 803 ext 1580    f-jakob.klh@mail.uni-wuerzburg.de   
Principal Investigator: Franz Jakob, Prof. Dr.         
Sub-Investigator: Lothar Seefried, Dr. med.         
Sponsors and Collaborators
Rainer Meffert
Crolll Gmbh
University of Wuerzburg
Investigators
Study Chair: Rainer Meffert, Prof. Dr. Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
  More Information

No publications provided

Responsible Party: Rainer Meffert, Director Department of trauma, hand, plastic and reconstrictive surgery, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01348269     History of Changes
Other Study ID Numbers: CZOL446HDE38T
Study First Received: May 2, 2011
Last Updated: September 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wuerzburg University Hospital:
bone marrow edema
Aclasta

Additional relevant MeSH terms:
Edema
Signs and Symptoms
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014