Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome - Full Text View

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:

MedlinePlus related topics: Edema

Drug Information available for: Zoledronic acid

U.S. FDA Resources

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

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 May 21, 2013

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