MedTrace Logo

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

NCT00051636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-05-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Paget's Disease of Bone

Interventions

DRUG

Zoledronic Acid

Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.

DRUG

Risedronate

Oral risedronate 30 mg capsules.

DRUG

Placebo to Risedronate

Oral placebo of risedronate capsules.

DRUG

Placebo to Zoledronic Acid

5 mL of sterile water one dose intravenous infusion.

DIETARY_SUPPLEMENT

Calcium and Vitamin D

Calcium and vitamin D supplements were supplied.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2004-03-31
Completion
2011-04-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00051636 on ClinicalTrials.gov