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

Novartis

Status and phase: Completed; Phase 3

Conditions: Paget's Disease of Bone

Treatments: Drug: Risedronate; Dietary Supplement: Calcium and Vitamin D; Drug: Placebo to Risedronate; Drug: Placebo to Zoledronic Acid; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051636

CZOL446H2304

ZOL446K2304 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 30 years or older
• Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)
• Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
• 90 days washout calcitonin
• 180 day washout bisphosphonate

Exclusion criteria

• Allergic reaction to bisphosphonates
• History of upper gastrointestinal disorders
• History of iritis, uveitis
• Calculated creatinine clearance < 30 ml/min at baseline
• Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups

Zoledronic Acid and Placebo to Risedronate

Experimental group

Description:

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.

Treatment:

Drug: Zoledronic Acid

Drug: Placebo to Risedronate

Dietary Supplement: Calcium and Vitamin D

Risedronate and Placebo to Zoledronic Acid

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to Zoledronic Acid

Dietary Supplement: Calcium and Vitamin D

Drug: Risedronate