NCT01348269已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Reduction of the Edema Area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
研究组 & 干预措施
Aclasta
Active Comparator
干预措施: Aclasta (Drug)
NaCl Solution
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of the Edema Area
时间窗: Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)
The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening
次要结局
- Number of Days of Illness(Assessment at week 6)
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(Week 3, 6)
- Reduction of Pain(Assessment at week 6)
- Quality of Life (Qualeffo-41 Questionnaire)(Assessment at week 6)
- Number of Aseptic Bone Necrosis and Fatigue Fractures(Baseline until end of study (week 12))
- Reduction of Pain (VAS)(Assessment at week 3)
- Subjective Estimation of Medical Condition (PDI)(Assessment at week 6)
- Number of Additional Medicinal Visits(Assessment at week 6)
研究者
Dr. Lothar Seefried
Dr. Lothar Seefried
Orthopaedische Klinik Koenig-Ludwig-Haus
研究点 (2)
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