Clinical Trial: Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Includ

Brief Summary: The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Patients Who Achieve Therapeutic Response at 6 Months. [ Time Frame: 6 months ]

Original Primary Outcome: Non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response

Current Secondary Outcome:

• Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 [ Time Frame: Baseline and day 28 ]
  The percent change in serum alkaline phosphatase from baseline to day 28 was measured.
• Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 [ Time Frame: Baseline and day 10 ]
  The percent change in serum C-telopeptide from baseline to day 10 was measured.
• Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 [ Time Frame: Baseline and day 10 ]
  The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.
• Time to First Therapeutic Response [ Time Frame: 182 days ]
  A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
• Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline [ Time Frame: Baseline and day 28 ]
  Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.
• Change in Pain Severity Score [ Time Frame: Baseline and day 182 ]
  Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
• Change in Pain Interference Score [ Time Frame: Baseline and day 182 ]
  Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
• Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period [ Time Frame: 8 years was the maximum ]
  Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.
• Number of Participants With a Partial Disease Relapse During the Extended Observation Period [ Time Frame: 8 years was the maximum ]
  Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.
• Number of Participants With a Disease Relapse During the Extended Observation Period [ Time Frame: 8 years was the maximum ]
  Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: February 14, 2005
Date Started: April 2002
Date Completion:
Last Updated: May 9, 2012
Last Verified: May 2012