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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Oral risedronate 30 mg capsules.
Oral placebo of risedronate capsules.
Number of Patients Who Achieve Therapeutic Response at 6 Months.
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
Time frame: 6 months
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
The percent change in serum alkaline phosphatase from baseline to day 28 was measured.
Time frame: Baseline and day 28
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
The percent change in serum C-telopeptide from baseline to day 10 was measured.
Time frame: Baseline and day 10
Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10
The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.
Time frame: Baseline and day 10
Time to First Therapeutic Response
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.
Time frame: 182 days
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.
Time frame: Baseline and day 28
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5 mL of sterile water one dose intravenous infusion.
Calcium and vitamin D supplements were supplied.
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Change in Pain Severity Score
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.
Time frame: Baseline and day 182
Change in Pain Interference Score
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.
Time frame: Baseline and day 182
Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
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.
Time frame: 8 years was the maximum
Number of Participants With a Partial Disease Relapse During the Extended Observation Period
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.
Time frame: 8 years was the maximum
Number of Participants With a Disease Relapse During the Extended Observation Period
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.
Time frame: 8 years was the maximum