NCT00404820

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

A Multi-center, Randomized, Open-label, Controlled, One-year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteopenia and Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Novartis · Industry
• Sex: Female
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-11-29
• Last updated: 2011-07-01
• Results posted: 2011-07-01

Locations

1 site across 1 country: Germany