The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
5 mg zoledronic acid in 5 mL of sterile water for infusion
5 mL of sterile water for infusion
30mg oral tablets overencapsulated to match the placebo capsules
Number of Patients Who Had Therapeutic Response at 6 Months
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
Time frame: Baseline, 6 months
Relative Change in Serum Alkaline Phosphatase in U/L at Day 28
The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.
Time frame: Baseline and 28 days
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 α-CTx in ug/mmol at Day 10
The percent change in urine α-CTx from baseline to Day 10 was measured.
Time frame: Baseline and day 10
Time to First Therapeutic Response
Therapeutic response was defined as a reduction of at least 75% from baseline 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
Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female \& male 20-58 years) and 35-115 U/L (female \& male \>58 years).
Time frame: Day 28
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oral capsules
Calcium and vitamin D supplements were supplied
Novartis Investigative site
Tucson, Arizona, United States
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Colorado Springs, Colorado, United States
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Change in Pain Severity at 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.
Time frame: Baseline and day 182
Change in Pain Interference at 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.
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 maximum