Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

PHASE2CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2005

Conditions
Postmenopausal
Interventions
DRUG

risedronate

tablet, 5 mg risedronate daily for 6 months

DRUG

risedronate

tablet, 100 mg risedronate monthly for 6 months

DRUG

risedronate

tablet, 150 mg risedronate monthly for 6 months

DRUG

experimental

tablet, 200 mg risedronate monthly for 6 months

Trial Locations (14)

Unknown

Research Site, Daytona Beach

Research Site, Gainesville

Research Site, Shawnee Mission

Research Site, San Antonio

Research Site, Hamilton

Research Facility, Montreal

Research Facility, Sainte-Foy

Research Facility, Zagreb

Research Facility, Amsterdam

Research Facility, Leiden

Research Facility, Bialystok

Research Site, Lublin

Research Site, Warsaw

Research Site, Wroclaw

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Warner Chilcott

INDUSTRY