NL-OMON24160已完成2 期
Zoledronic acid as Disease-modifying drug in Knee osteoarthritis (ZODIAK)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age between 40 and 70 years. - Primary tibiofemoral (TF) knee osteoarthritis (OA) according to clinical and radiographic American Collega of Rheumatology criteria. When two knees are eligible, the most painful knee is chosen as index knee. When knees are equally painful the index knee will be selected randomly. The most affected compartment (MAC) of the index is defined as the TF compartment with the most radiographic joint space loss. - Pain in the index knee on at least 50% of the days of the previous month (numeric rating scale between 4/10 and 8/10). - At least one bone marrow lesion (BML) in the MAC of the index knee on MRI, as judged by a trained researcher. A BML is defined on T2-weighted MRI sequences as a zone of altered signal intensity in the bone and marrow, located immediately beneath the articular cartilage and visible on at least two consecutive slices.
排除标准
- •- Severe structural osteoarthritis (OA) of the most affected compartment of the index knee on plain radiograph: grade 3 radiographic joint space narrowing of the index knee, according to the Osteoarthritis Research Society International atlas. - Planned or expected surgery of index knee in the next 2 years (physician judgment). - Intra-articular injection into the index knee: glucocorticoids, hyaluronic acid, or platelet-rich plasma within the last 6 months. - Secondary OA, such as secondary to inflammatory joint disease, significant trauma, metabolic disease, and/or extreme varus or valgus position of the knee (i.e. >10º). - Knee pain from other causes than OA, such as fibromyalgia or (pseudo)radicular syndrome. - Other self-reported diseases with potential effects on current bone metabolism (e.g. thyroid or parathyroid disease, malignancy, bone fracture within past 6 months). - Self-reported disease that limits intestinal absorptive capacity (e.g. celiac disease or short bowel syndrome). - Previous allergic reaction to zoledronic acid, another bisphosphonate, or other substances in the solute. - Previous and/or current use of bisphosphonates, denosumab, teriparatide, strontium ranelate, calcitonin and/or raloxifene. - Current use of loop diuretics, glucocorticoids, aminoglycoside antibiotics. - Uncontrolled or actively treated dental disease and/or otitis. - Current or previous atrial fibrillation. - Abnormal blood tests: serum ionized calcium >1.32 mmol/l or <1.15 mmol/l, serum (25OH) vitamin D <50 nmol/l, or estimated creatinine clearance <60 ml/min. - Contraindications to MRI (e.g. claustrophobia, MRI-incompatible devices/implants/foreign objects). - Insufficient ability to communicate in Dutch. - Pregnancy or lactation. - Other factors that prevent subjects from adhering to the protocol.
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