NL-OMON50547已完成2 期
ZOledronic acid as DIseAse-modifying drug in Knee osteoarthritis (ZODIAK) - ZODIAK
niversitair Medisch Centrum Utrecht0 个研究点目标入组 86 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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 OA according to clinical and radiographic ACR
- •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 (NRS
- •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 OA of the MAC 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
- •- Intra-articular injection into the index knee: glucocorticoids, hyaluronic
- •acid, or platelet-rich plasma within the last 6 months.
- •- Knee pain from other causes than knee OA (e.g. fibromyalgia)
- •- 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. more than 10º).
- •- 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 higher than 1.32 mmol/l or lower
- •than 1.15 mmol/l, serum (25OH) vitamin D lower than 50 nmol/l, or estimated
- •creatinine clearance lower than 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.
研究者
相似试验
已完成
2 期
Zoledronic acid as Disease-modifying drug in Knee osteoarthritis (ZODIAK)NL-OMON24160niversity Medical Center Utrecht86
进行中（未招募）
1 期
Zoledronic acid in patients with metastatic prostate cancer treated with abiraterone acetate: impact on bone mineral densityMetastatic castration-resistant prostate cancerMedDRA version: 18.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001146-34-FRCentre Oscar Lambret
招募中
4 期
Effect of Zoledronic Acid in Primary Knee OsteoarthritisPrimary OsteoarthritisNCT06051344Toufiqe-E-Ealahi92
进行中（未招募）
1 期
Effect of zoledronic acid on osteoarthritis of the hipInvestigated disease is osteoarthritis of the hip with concurrent Bone marrow lesionsEUCTR2019-000757-31-NOSouth-east health region of Noway70
进行中（未招募）
1 期
Zoledronic acid for prevention of bone loss after bariatric surgeryMorbid obese subjects undergoing bariatric surgeryEUCTR2019-001650-26-DKHospital South West Jutland70