Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

604

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Osteoporosis
Interventions
DRUG

Zoledronic acid 5 mg solution

Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.

DRUG

Alendronate 70 mg tablets

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.

DRUG

Calcium/Vitamin D

Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

Trial Locations (1)

Unknown

For site information contact Novartis Pharmaceuticals, Multiple Cities

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00404820 - Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis | Biotech Hunter | Biotech Hunter