TRANSDERMAL BISPHONSPHONATE ZOLENDRATE IN PAGETS DISEASE

$293,069M01FY2001RRNIH

Duke University, Durham NC

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Abstract

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.

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