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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 假设：抑制破骨细胞和/或成骨细胞活化可下调对血管闭塞的病理生理反应，并减轻镰状细胞病（SCD）的疼痛和疼痛症状。 具体目的：在接受1剂或2剂唑来膦酸（ZA）的SCD患者中： " 评价ZA的安全性和毒性，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 " 观察并在可行的范围内比较给药方案之间骨代谢标志物CTX、骨特异性碱性磷酸酶（BSAP）、炎症和疼痛标志物的变化。

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.