A prospective, bicentric, randomised, primarily double blind, placebo-controlled study to evaluate the efficacy of zoledronic acid for the treatment of bone marrow syndrome

• Conditions: Determination of efficacy of Zoledronic Acid on the treatment of bone marrow edema syndrome.; MedDRA version: 14.1Level: LLTClassification code 10064277Term: Bone marrow edema syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2010-019415-38-DE
• Lead Sponsor: niversitätsklinikum Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-04
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 estrogentest)
- 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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 hyperparathyreoidism, 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified