Trial Outcomes & Findings for Re-treatment of Participants With Paget's Disease Using Zoledronic Acid (NCT NCT00740129)

A total of 6 participants from core studies CZOL44K2304 and CZOL44K2305 who met the definition of responders at the end of study visit but later relapsed during the extension of observation period took part in the study at 5 investigative sites in Canada, Spain, New Zealand and, South Africa from 21 October 2008 to 14 March 2011.

Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Normalization of serum alkaline phosphatase (SAP) occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age \> 58 years old, respectively. Last observation carried forward (LOCF) was defined as the last post-baseline SAP value prior to month 6 for a participant who did not have an SAP value at month 6.

The percentage change in SAP at Months 3 and 6 relative to baseline were measured.

Normalization of SAP occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age \> 58 years old, respectively.

Adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition that occurred after starting the study drug even if the event was not considered to be related to study drug. TEAEs were defined as AEs that were absent prior to, but occurred after the i.v. infusion of study drug. TEAEs also included those that were present prior to the i.v. study drug infusion (i.e., as part of the extended observation period) but occurred at an increased severity after the i.v. infusion of study drug.