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

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

MedlinePlus related topics:

Menopause Osteoporosis

ChemIDplus related topics:

Alendronate Alendronate sodium Zoledronic acid

U.S. FDA Resources

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

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
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (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

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446HDE31
First Received:	November 28, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00404820
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 Diseases, Metabolic

Bone Diseases

Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

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