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

PHASE3CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

January 31, 2001

Primary Completion Date

March 31, 2004

Study Completion Date

April 30, 2011

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.

Trial Locations (34)

10029

Novartis Investigative Site, New York

13210

Novartis investigative site, Syracuse

27710

Novartis investigative site, Durham

33101

Novartis Investigative Site, Miami

33433

Novartis Investigative Site, Boca Raton

48021

Novartis investigative site, Detroit

60153

Novartis Investigative site, Maywood

80227

Novartis Investigative Site, Lakewood

90414

Novartis Investigative Site, Santa Monica

97504

Novartis investigative site, Medford

01601

Novartis investigative site, Worcester

02908

Novartis investigative site, Providence

Unknown

Novartis Investigative Site, Concord

Novartis Investigative Site, Fitzroy

Novartis Investigative site, Geelong

Novartis Investigative Site, Kogarah

Novartis Investigative site, Maroochydore

Novartis Investigative site, Nedlands

Novartis Investigative Site, Calgary

Novartis Investigative Site, London

Novartis Investigative Site, Montreal

Novartis Investigative Site, Ste-Foy

Novartis Investigative Site, Toronto

Novartis Investigative site, Auckland

Novartis Investigative Site, Christchurch

Novartis Investigative site, Salamanca

Novartis Investigative site, Liverpool

Novartis Investigative Site, Manchester

Novartis Investigative site, Nottingham

Novartis Investigative Site, Oxford

Novartis Investigative site, Penarth

Novartis investigative site, Pernarth

Novartis Investigative Site, Stanmore

Novartis Investigative Site, Vale of Glamorgan

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY