Myeloproliferative Neoplasms and Bone Structure
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative neoplasm) to the bone.
The hypothesis is that patients with CMPN have a higher fracture-rate compared to the background population. We expect to find a lower BMD using conventional DXA scan (dual energy x-ray absorptiometry), and a change in other parameters using HR-pQCT (high-resolution peripheral quantitative computerized tomography).Biochemical bone markers is measured to support the hypothesis.
详细描述
This is a clinical study to evaluate the effect of CMPN to the bone.
Three individual cohorts are defined; a cohort consisting of 50 patients with Polycythemia Vera (PV), a cohort consisting of 50 patients with Essential Thrombocythemia (ET), and a cohort consisting of 25 patients with Primary Myelofibrosis (PMF).
Patients are recruited from the Department of Hematology, Odense University Hospital.
Interventions consist of:
- Conventional DXA scan to measure Bone Mineral Density (BMD).
- Experimental HR-pQCT to assess geometry, strength and microstructure of the bone in 3 dimension.
- Blood-samples are collected and frozen for later analyses of Biochemical Bone Markers: 1-CTP, Ctx, ALP (alkaline phosphatase)and P1NP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Diagnosis of PV (according to WHO 2008 criteria), only JAK2-pos.(Janus kinase 2)
- •Diagnosis of ET (according to WHO 2008 criteria), only JAK2-pos.
- •Diagnosis of PMF (according to WHO 2008 criteria)independent of JAK2-status.
排除标准
- •Pregnancy
- •Bone Diseases (Mb. Pagets, Myelomatosis, MGUS (monoclonal gammopathy of undetermined significance), osteogenesis imperfecta, Prim. hyperparathyroidism, osteomalacia.
- •Drugs (Prednisone>3 mth, anti-osteoporotic drugs, anti-estrogen drugs.
- •Presence of any psychologic condition or language barrier, which may interfere which a complete understanding, and arise ethnical considerations.
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: 1 day
Patients will undergo one DXA scan independent of time of CMPN diagnosis
次要结局
- Evaluation of Geometry, Strength and Micro-Structure of the bone.(1 day)
研究者
Sarah Farmer
MD
University of Southern Denmark