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

Primary Purpose

Bone Marrow Edema

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Aclasta
Placebo
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Edema focused on measuring bone marrow edema, Aclasta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg
  • Department of trauma, hand, reconstructive and plastic, University of Wuerzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aclasta

NaCl Solution

Arm Description

Outcomes

Primary Outcome Measures

Reduction of the Edema area

Secondary Outcome Measures

Reduction of pain (VAS)
Quality of life (Qualeffo-41 questionnaire - Quality of life questionnaire of the European Foundation for Osteoporosis)
Subjective estimation of medical condition (PDI)
Number of additional medicinal visits
Number of days of illness
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP

Full Information

First Posted
May 2, 2011
Last Updated
June 7, 2017
Sponsor
Wuerzburg University Hospital
Collaborators
Crolll Gmbh, University of Wuerzburg
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1. Study Identification

Unique Protocol Identification Number
NCT01348269
Brief Title
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Acronym
ZoMARS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
August 26, 2015 (Actual)
Study Completion Date
August 26, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
Crolll Gmbh, University of Wuerzburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Edema
Keywords
bone marrow edema, Aclasta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclasta
Arm Type
Active Comparator
Arm Title
NaCl Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aclasta
Intervention Description
1 x intravenous non-current drip (infusion)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl Solution
Primary Outcome Measure Information:
Title
Reduction of the Edema area
Time Frame
Week 6 after study start
Secondary Outcome Measure Information:
Title
Reduction of pain (VAS)
Time Frame
Week 0, 3, 6
Title
Quality of life (Qualeffo-41 questionnaire - Quality of life questionnaire of the European Foundation for Osteoporosis)
Time Frame
Week 0, 3, 6
Title
Subjective estimation of medical condition (PDI)
Time Frame
Week 0, 3, 6
Title
Number of additional medicinal visits
Time Frame
Week 3, 6
Title
Number of days of illness
Time Frame
Week 3, 6
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP
Time Frame
Week 3, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Meffert, Prof. Dr.
Organizational Affiliation
Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97074
Country
Germany
Facility Name
Department of trauma, hand, reconstructive and plastic, University of Wuerzburg
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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