Official Title: “A Multi-Center, Randomized, Open-Label, Controlled, One-Year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Post Menopausal Women With Osteopenia and Osteoporosis”

The aim of this study is to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Zoledronic acid
• Drug: Alendronate

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Change in bone metabolism marker NTx as measured throughout the 12 month treatment period

Secondary Measures

• Change in bone metabolism marker P1NP throughout the 12 month treatment period
• Quality of Life measured on baseline and after 12 month

Inclusion Criteria:

• Low bone mineral density (as indicated by a "T-Score" of -2.0 or lower) postmenopausal women

Exclusion Criteria:

• previous use of oral and i.v. bisphosphonates, PTH, strontium ranelate, sodium fluoride.
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals +41 61 324 1111 Study Director Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404820

Study ID Number: CZOL446HDE31

ClinicalTrials.gov Identifier: NCT00404820

Health Authority: Germany: Federal Institute for Drugs and Medical Devices