Conditions: Paget's Disease of Bone
Keywords: Bisphosphonate SAP SAP excess non-inferiority therapeutic response extended observation period
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

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 description:

Arms:
arm 1: Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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: Risedronate intervention 3: Placebo to Risedronate intervention 4: Placebo to Zoledronic Acid intervention 5: Calcium and Vitamin D
Intervention descriptions: intervention 1: Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion. intervention 2: Oral risedronate 30 mg capsules. intervention 3: Oral placebo of risedronate capsules. intervention 4: 5 mL of sterile water one dose intravenous infusion. intervention 5: Calcium and vitamin D supplements were supplied.

Protocol document: