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

This study has been completed.

First Received: November 28, 2006 Last Updated: May 7, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00404820

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Zoledronic acid Drug: Alendronate	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Alendronate Zoledronic acid Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	October 2006
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Zoledronic acid
2: Active Comparator	Drug: Alendronate

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Female

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404820

Locations

Germany
For site information contact Novartis Pharmaceuticals
Multiple Cities, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals +41 61 324 1111

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446HDE31
Study First Received:	November 28, 2006
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00404820 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Osteoporosis
Bisphosphonate
Biomarker

zoledronic acid
alendronate
post-menopausal

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Alendronate
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Menopause

Additional relevant MeSH terms:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs

Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009