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: placebo to zoledronic acid; Drug: Calcium and vitamin D supplements; Drug: Risedronate; Drug: Placebo to risedronate; Drug: zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00103740

CZOL446H2305

ZOL446K2305 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 30 years or older
• SAP 2 times 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 GI disorders
• History of iritis, uveitis
• Calculated creatinine clearance < 30 ml/min at baseline
• Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

185 participants in 2 patient groups

Zoledronic acid and placebo to risedronate

Experimental group

Description:

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.

Treatment:

Drug: zoledronic acid

Drug: Placebo to risedronate

Drug: Calcium and vitamin D supplements

Risedronate and placebo to zoledronic acid

Active Comparator group

Description:

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.

Treatment:

Drug: placebo to zoledronic acid

Drug: Risedronate

Drug: Calcium and vitamin D supplements