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

PHASE3CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

April 30, 2002

Primary Completion Date

December 31, 2003

Study Completion Date

April 30, 2011

Conditions
Paget's Disease of Bone
Interventions
DRUG

zoledronic acid

5 mg zoledronic acid in 5 mL of sterile water for infusion

DRUG

placebo to zoledronic acid

5 mL of sterile water for infusion

DRUG

Risedronate

30mg oral tablets overencapsulated to match the placebo capsules

DRUG

Placebo to risedronate

oral capsules

DRUG

Calcium and vitamin D supplements

Calcium and vitamin D supplements were supplied

Trial Locations (41)

13210

Novartis Investigative Site, Syracuse

29209

Novartis Investigative Site, Columbia

44195

Novartis Investigative Site, Cleveland

46202

Novartis Investigative Site, Indianapolis

53592

Novartis Investigative Site, Madison

70121

Novartis Investigative Site, New Orleans

80901

Novartis Investigative Site, Colorado Springs

85732

Novartis Investigative site, Tucson

97504

Novartis Investigative Site, Medford

02114

Novartis Investigative Site, Boston

Unknown

Novartis Investigative Site, Fitzroy

Novartis Investigative Site, Kogarah

Novartis Investigative site, Newcastle

Novartis Investigative Site, Parkville

Novartis Investigative site, St Leonards

Novartis Investigative site, Brussels

Novartis Investigative Site, Ghent

Novartis Investigative Site, Montreal

Novartis Investigative Site, Angers

Novartis Investigative Site, Dreux

Novartis Investigative Site, Marseille

Novartis Investigative Site, Nice

Novartis Investigative Site, Paris

Novartis Investigative Site, Rouen

Novartis Investigative Site, Toulouse

Novartis Investigative Site, Berlin

Novartis Investigative Site, Frankfurt

Novartis Investigative Site, Leipzig

Novartis Investigative Site, Leverkusen

Novartis Investigative Site, Wirzburg

Novartis Investigative site, Christchurch

Novartis Investigative site, Cape Town

Novartis Investigative site, Barcelona

Novartis Investigative site, Madrid

Novartis Investigative Site, Málaga

Novartis Investigative Site, Salamanca

Novartis Investigative site, Santiago de Compostela

Novartis Investigative Site, Valencia

Novartis Investigative Site, Liverpool

Novartis Investigative Site, London

Novartis Investigative site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY