Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome (NCT01348269) | Clinical Trial Compass
CompletedPhase 3
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Germany48 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Reduction of the Edema Area
Timeframe: Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)