Conditions: Paget's Disease of Bone
Keywords: Zoledronic acid, risedronate, Paget's disease of bone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 185
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. arm 2: Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Interventions: intervention 1: zoledronic acid intervention 2: placebo to zoledronic acid intervention 3: Risedronate intervention 4: Placebo to risedronate intervention 5: Calcium and vitamin D supplements
Intervention descriptions: intervention 1: 5 mg zoledronic acid in 5 mL of sterile water for infusion intervention 2: 5 mL of sterile water for infusion intervention 3: 30mg oral tablets overencapsulated to match the placebo capsules intervention 4: oral capsules intervention 5: Calcium and vitamin D supplements were supplied

Protocol document: