CLINICAL TRIAL: PILOT/PHASE 1 STUDY OF ZOLEDRONIC ACID (ZOMETA ) IN SICKLE CELL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 假设：抑制破骨细胞和/或成骨细胞的激活可能下调血管闭塞的病理生理反应，减轻镰状细胞病(SCD)的疼痛和疼痛症状 具体目标：在接受1或2剂唑来膦酸(ZA)治疗的SCD患者中： “评估ZA的安全性和毒性时要注意牙齿健康(特别是ONJ)、肾功能、红细胞和网织红细胞计数、肝脏健康和血清电解质。 观察骨代谢标志物CTX、骨特异性碱性磷酸酶(BSAP)、炎症和疼痛标志物的变化，并在可行的情况下对不同给药方案进行比较。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Inhibition of osteoclast and/or osteoblast activation may down-modulate pathophysiological responses to vaso-occlusion and diminish pain and pain symptoms in Sickle Cell Disease (SCD) Specific Aims: In patients with SCD receiving either 1 or 2 doses of zoledronic acid (ZA): " Evaluate the safety and toxicity of ZA with attention to dental health (specifically, ONJ), renal function, red blood and reticulocyte count, liver health and serum electrolytes " Observe, and to the extent feasible compare between dosing regimens, changes in markers of bone metabolism CTX, bone specific alkaline phosphatase (BSAP), markers of inflammation and pain.