TRANSDERMAL BISPHONSPHONATE ZOLENDRATE IN PAGETS DISEASE

透皮双膦酸盐 ZOLENDRATE 在佩吉特病中的应用

• 批准号: 6112792
• 负责人: KENNETH W. LYLES
• 金额: $ 4.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112792
• 关键词: clinical research; diphosphonate; dosage; drug administration routes; drug screening /evaluation; human subject; human therapy evaluation; osteitis deformans; pathologic bone resorption; skeletal disorder chemotherapy; clinical research; diphosphonate; dosage; drug administration routes; drug screening /evaluation; human subject; human therapy evaluation; osteitis deformans; pathologic bone resorption; skeletal disorder chemotherapy

Paget's disease of bone is a chronic progressive skeletal disorder of unknown etiology caused by an increase in bone remodeling (osteoclastic resorption and osteoblastic formation) leading to bone pain and skeletal deformities. The purpose of this study was to determine if administration of Zolendronate transdermally would cause therapeutic responses in at least 40% of patients with Paget's disease of bone as evidenced by a 50% reduction in bone resorption (dexoy pyridoline/creatinine and hydroxyproline/creatinine ratio) and bone formation (serum alkaline phosphatase and bone alkaline phosphatase levels). In this trial, two different concentrations, 2 mg/ml and 5 mg/ml in two different size transdermal systems, 10 cm2 and 25 cm2 were to be studied. This protocol was terminated at the end of December 1996 because the Zolendronate delivered by way of a transdermal patch was incapable of lowering markers of bone resorption and bone formation seen in Paget's disease of bone. Therefore, this study was terminated. There are no publications from this protocol.

Paget的骨骼疾病是一种慢性进行性骨骼疾病，是由于骨头疼痛和骨骼畸形导致骨骼重塑（整骨碎屑的吸收和成骨细胞形成）的增加而引起的。这项研究的目的是确定至少40％的Paget患有Paget骨骼疾病的患者的Zolendronate是否会引起治疗反应，这证明了骨吸收降低50％（Dexoy吡idoline/肌酐/肌酐和羟基肌氨酸/肌酐/肌酐比率）和骨形成量（骨化）和骨化骨磷酸盐酶和骨化量。在这项试验中，将研究两个不同的浓度，2 mg/ml和5 mg/ml，在两个不同尺寸的透皮系统中，将研究10 cm2和25 cm2。该方案于1996年12月底终止，因为通过透皮斑提供的Zolendronate无法降低Paget骨骼疾病中骨吸收和骨形成的标记。因此，这项研究被终止。该协议没有出版物。